Author: Raymond McBride

Manufacturers should work diligently to transition medical devices

The Secretary of the Department of Health and Human Services (HHS), Xavier Becerra, has extended the Public Health Emergency (PHE) for the twelfth time on January 11, 2023, as a consequence of the Coronavirus Disease 2019 (COVID-19) pandemic.[1] As a result, liability protections granted to medical device manufacturers by virtue of this declaration will continue for now. However, once this declaration is ended, medical device manufacturers who received such protections will need to consider what actions they will need to take in order to insure that their products can lawfully remain on the market. This article addresses the strategies and considerations medical device manufacturers should take in preparation for the termination of the COVID-19 pandemic and PHE to ensure a smooth transition of their devices on the market back to the pre-COVID-19 regulatory scheme.

Former HHS Secretary Alex Azar initially declared the PHE on January 31, 2020, nationwide, [2] pursuant to section 319 of the Public Health Service Act.[3] Termination of the PHE is determined upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first.[4] The renewed PHE is effective through April 11, 2023, unless terminated by the Secretary sooner.  HHS has indicated it will give at least a 60-day notice of termination before the PHE ends.[5] This notice would need to occur between now and March 12, 2023.  Whether the PHE is renewed for the thirteenth time depends on a multitude of factors and COVID-19 circumstances, but many believe that the end of the pandemic may be in sight sometime this year. 

Once the PHE was declared, the U.S. Food and Drug Administration (FDA or “Agency”), to foster the development and availability of medical products that would assist in combating the pandemic, issued Emergency Use Authorizations (EUAs) to certain device manufacturers to encourage innovation and manufacturing of products that, among other things, would provide protection from and treatment for the COVID-19 virus. These EUAs allow manufacturers to market and distribute unapproved medical products, or allow an unapproved use of an approved medical product in certain situations. The EUAs, issued by the FDA pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)[6] and ensuing guidances, altered the usual standards and enforcement policies to help expand the availability of medical products during the time of the PHE. Once the COVID-19 PHE comes to an end, however, the FDA will revert to its normal operations, whereby all stakeholders, including device manufacturers, healthcare facilities, healthcare providers, patients, and consumers will need to adjust from policies adopted and implemented during the declared COVID-19 PHE back to pre-PHE times. 

Emergency Use Authorization
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) authorizes the FDA to issue EUAs,[7] once the Secretary declares that an EUA declaration is appropriate.[8] Shortly after the initial declaration of the COVID-19 PHE, the Secretary of HHS also determined that “there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad,”[9] involving the virus that causes COVID-19, now known as SARS-CoV-2, thereby justifying the emergency use of medical devices and in vitro diagnostics for detection, diagnosis and/or treatment of SARS-CoV-2. Just in the year following the EUA declaration, the FDA reviewed over 2,300 EUA requests and issued more than 600 EUAs for medical countermeasures to combat COVID-19.[10]

Termination of an EUA declaration
Unlike the section 319 PHE declaration that expires if not extended, an EUA declaration under section 564 generally continues until the HHS Secretary terminates it. Thus, an EUA may remain in effect beyond the duration of the PHE. The HHS Secretary can terminate an EUA declaration on the earlier determination by the HHS Secretary that “the circumstances that precipitated the declaration have ceased (after consultation as appropriate with the Secretary of Homeland Security or the Secretary of Defense),” or “a change in the approval status of the product such that the authorized use(s) of the product are no longer unapproved (section 564(b)(2)),”[11] as in the case of an unapproved product distributed and used under an EUA that was subsequently approved by the FDA for the use allowed by the EUA. The Secretary shall provide advance notice that a declaration will be terminated and “the period of advance notice shall be a period reasonably determined”[12] to allow sufficient time for the disposition and transition of the unapproved product. The FDA has suggested the period of advance notice be 180 days before the day on which the EUA declaration is terminated.[13],[14]

Enforcement discretion
The FDA creates, implements and enforces its regulations, which are based on the laws set forth in the FD&C Act or other laws under which the Agency operates. These regulations have the full force of law. However, the FDA, as well as other government agencies, may choose to apply enforcement discretion as in the case where a medical product falls under the regulatory scheme of medical devices within its purview, but the FDA chooses not to enforce the requirements when the risk to patients is low.[15] Thus, while the legal obligations of the FDA in overseeing and regulating drugs and medical devices remain in effect technically, the Agency may issue enforcement policies to inform the public that it will not seek to enforce certain provisions of the statutes in enumerated situations under the COVID-19 PHE and EUA declarations.[16] During the COVID-19 PHE, the FDA issued a number of guidances outlining its enforcement policies concerning medical devices to address supply issues and ensure access to care, and to give health care providers the flexibilities needed to respond to COVID-19 and help keep people safer.[17],[18] For example, these guidances typically recite an enforcement policy indicating that the “FDA does not intend to object to modifications to the indications or design of FDA cleared or approved devices … without prior submission of a premarket notification or premarket approval application supplement where the modification does not create an undue risk in light of the public health emergency.”[19] The FDA applied enforcement discretion to numerous other medical devices such as ventilators, in vitro diagnostics, sterilizers, infusion pumps and digital health devices, among others.[20]

Transitioning medical devices
It is not clear when the COVID-19 PHE declaration or the EUA declaration may end, but as discussed above, the Secretary of HHS is required to provide advance notice of termination of the PHE[21] and EUA.[22] In preparation for transitioning medical devices back to pre-EUA normal operations, the FDA issued two draft guidances (“transition guidances”) directed at device manufacturers, healthcare facilities, healthcare providers, patients, consumers and FDA “to adjust from policies adopted and operations implemented during the declared COVID-19 [PHE] to normal operations.”[23],[24] The key features outlined in these transition guidances include:

  • The timeline for withdrawal of the enforcement policy guidances issued during the COVID-19 PHE and the advance notice of termination of each EUA issued during the EUA declaration
  • Manufacturer notice of intent to distribute its device after withdrawal of the enforcement guidances
  • Submissions of marketing applications prior to EUA termination date
  • Products continued to be marketed after EUA termination 

The FDA anticipates the final transition guidances will likely be issued early 2023. It is highly advised that manufacturers carefully consider strategies and options for transitioning their medical devices when the relevant EUAs and COVID-19-enforcement policies cease to be in effect. While these most likely will terminate at the same time, an EUA declaration under section 564 may remain in effect beyond the duration of the PHE.

Timeline
The FDA is proposing a 180-day transition period beginning on the “implementation date” and ending on the date enforcement guidances are withdrawn.[25] The FDA lists 17 enforcement policies that will be effected by the draft guidance.[26] The transition plan is a phased approach allowing manufacturers to become compliant with applicable statutory and regulatory requirements once the policies are no longer in effect and the more stringent requirements are reinstated. Manufacturers are still expected to comply with all statutory and regulatory requirements applicable to their devices, such as adverse event reporting requirements, during this period under 21 CFR Part 803, and submit reports consistent with FDA guidance,[27] and, if not already doing so, prepare marketing submissions if applicable. The FDA also proposes a similar timeline for termination of EUAs whereby advance notice of the “EUA termination date” will be published in the Federal Register 180 days before the EUA declaration is terminated.[28] Manufacturers also must continue to comply with the terms of the device’s EUAs as well as statutory and regulatory requirements applicable to their devices following the notice of the termination date. 

Notifications of intent and transition implementation plan
The FDA recommends medical device manufacturers notify the Agency whether or not they intend to submit a marketing application to continue distributing their devices after the termination date. It also encourages that communications with the Agency begin early and that the “Notifications of Intent” be submitted within 90 days following notice of termination. If a manufacturer does not intend to continue to distribute its device, it should follow 21 CFR Part 806 for the reporting requirements of any correction or removal of a medical device(s). The Agency does note that it will not object (i.e., apply its enforcement discretion) to the disposition of certain devices, such as single use and reusable non-life-supporting/non-life-sustaining devices that were distributed prior to the guidance withdrawal or EUA termination date. However for reusable devices, the device should be restored to the previously FDA-cleared or approved version of the device, or have publicly available labeling that accurately describes the product features and regulatory status (i.e., device lacks FDA clearance or approval). For life-supporting/life-sustaining devices, the FDA recommends devices should have both publicly available and a physical copy of the labeling.[29] In vitro diagnostic devices that remain distributed are to be used no more than two years after the EUA termination date or until the expiration date, whichever is less.[30]

For manufacturers planning to continue to distribute medical devices after the termination date, a marketing application should be submitted to the FDA allowing sufficient time to get through the “refuse to accept” process for 510(k) medical devices[31] and/or the “acceptance and filing review” process for premarket approvals[32] or De Novo classification requests[33] before the termination and withdrawal date. Marketing submissions are expected to be submitted to the Agency and approved prior to the withdrawal of the enforcement guidances. The FDA describes hypothetical scenarios to illustrate the policies outlined in the transition guidances. A key recommendation for manufacturers to include in their marketing submissions is a “transition implementation plan” that addresses the manufacturer’s plan for devices already distributed in the case of a positive or negative Agency decision.[34]  The Agency notes that it will not object to the continued distribution of devices as long as the manufacturer’s marketing submission has been submitted to and accepted by the FDA before the EUA termination date and the FDA has not taken a final action on the marketing submission.[35]  In cases where a manufacturer receives a negative decision from the FDA on its marketing submission for a product that has been distributed under an EUA prior to the termination date, the transition implementation plan is recommended to include:[36]

  • An estimated number of devices that are currently under an EUA in distribution in the U.S.
  • A manufacturer’s benefit-risk based plan and explanation for disposition of already distributed devices
  • A description of the process for notifying patients, consumers, healthcare facilities, healthcare  providers and distributors of the device’s regulatory status (i.e., device lacks FDA clearance or approval)
  • A description of the process and timeline for restoring distributed devices to the previously FDA-cleared or approved version of the devices, with publicly available labeling (and a physical copy if applicable)
  • A description of the maintenance plan for distributed devices

For manufacturers receiving a positive decision on their marketing submission, the transition implementation plan should include:[37]

  • An estimated number of devices that are currently under an EUA in distribution in the U.S.
  • A description of the process for notifying patients, consumers, healthcare facilities, healthcare providers and distributors of the device’s regulatory status (i.e., FDA cleared or approved)
  • A description of the process and timeline for providing to users of previously distributed devices updated labeling or components that reflect any changes made to the cleared or approved device

Although the FDA provides hypothetical scenarios to exemplify the timeline and expectations of the transition policy, it also recognizes that there may be unique situations raising compliance issues not covered.  To that extent, the Agency suggests manufacturers to initiate discussions through the Q-Submission Program (including Pre-Submissions) in order to develop a plan to address specific scenarios.[38]  As with all FDA guidance, these draft transition guidances — when finalized — will contain nonbinding recommendations and represent the FDA’s current view on the topic, but does not have the force and effect of law.

Conclusion
The COVID-19 pandemic will come to a welcomed end. As the supply chain crisis eases, the need for emergency measures will diminish, the continuity of patient care will be restored, and the burdens on our health care system will decrease. The FDA believes an orderly and transparent transition is appropriate for devices that fall within the scope of its guidances and encourages manufacturers to work toward a marketing submission before the termination date. The Agency intends to help facilitate this process by working with manufacturers during this transition period to avoid exacerbating product shortages and supply chain disruptions. The PHE and EUA declarations will terminate at some point and it is incumbent on manufacturers to work diligently to transition their medical devices in a timely manner without overwhelming FDA resources. In the post-COVID-19 PHE/EUA era, the FDA will likely increase the scrutiny of medical devices to assure proper transitioning  and to protect the public health by ensuring safety and efficacy. The FDA recognizes that continued flexibility is necessary, while still providing necessary oversight, and expects manufacturers to prepare early.

George Hajduczok, J.D., Ph.D., F.A.H.A., is special counsel at Phillips Lytle LLP and a member of the firm’s Life Sciences & Health Effects Practice Team. He can be reached at (716) 504-5772 or ghajduczok@phillipslytle.com.

Eric M. Kraus is a partner at Phillips Lytle LLP and co-leader of the firm’s Life Sciences & Health Effects Practice Team. He can be reached at (212) 508-0408 or ekraus@phillipslytle.com.


[1] Admin. for Strategic Preparedness & Response, Renewal of Determination That a Public Health Emergency Exists (Jan. 11, 2023), https://aspr.hhs.gov/legal/PHE/Pages/covid19-11Jan23.aspx.

[6] Section 564 was first added to the FD&C Act by the Project BioShield Act of 2004 (Pub. L. No.  108-276, 188 Stat. 835 (July 21, 2004) and amended or added by the Pandemic & All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), Pub. L. 113-5, 127 Stat. 161 (Mar. 13, 2013). (Among other things, PAHPRA added sections 564A and 564B to the Federal Food, Drug, and Cosmetic (FD&C) Act to provide new authorities for the emergency use of approved products in emergencies and products held for emergency use.)

[7] Pandemic & All-Hazards Preparedness Reauthorization Act of 2013, Pub. L. 113-5, 127 Stat. 161 (Mar. 13, 2013).

[9] U.S. Dep’t of Health & Human Servs., Determination of a public health emergency and declaration that circumstances exist justifying authorizations pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3 (Feb. 4, 2020), https://www.fda.gov/media/135010/download.

[11] U.S. Food & Drug Admin., supra note 8, at 6.

[12] 21 U.S.C. § 360bbb-3(b)(3).

[13] U.S. Food & Drug Admin., Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Draft Guidance for Industry and Food and Drug Administration Staff (Dec. 2021), https://www.fda.gov/media/155038/download.

[14] U.S. Food & Drug Admin., Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Draft Guidance for Industry and Food and Drug Administration Staff  (Dec. 2021), https://www.fda.gov/media/155039/download.

[16] Courts have generally held that when an agency adopts a policy where it refrains from bringing an enforcement action, such non-enforcement decisions are “committed to agency discretion” and not subject to judicial review under the Administrative Procedure Act (APA) (5 U.S.C. § 701(a)(2)). (See Heckler v. Chaney, 470 U.S. 821, 831 (1985) (noting that an enforcement decision “often involves a complicated balancing of a number of factors which are peculiarly within its expertise.  Thus, the agency must not only assess whether a violation has occurred, but whether agency resources are best spent on this violation or another, whether the agency is likely to succeed if it acts, whether the particular enforcement action requested best fits the agency’s overall policies, and, indeed, whether the agency has enough resources to undertake the action at all. An agency generally cannot act against each technical violation of the statute it is charged with enforcing.  The agency is far better equipped than the courts to deal with the many variables involved in the proper ordering of its priorities.” Furthermore, “an agency’s decision not to take enforcement action should be presumed immune from judicial review under § 701(a)(2)” of the APA). Id. at 831-32  (emphasis added))

[18] U.S. Food & Drug Admin., supra note 15, at 4-6.

[19] U.S. Food & Drug Admin., Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Guidance for Industry and Food and Drug Administration Staff, at 9 (April 2020), https://www.fda.gov/media/136734/download.

[20] U.S. Food & Drug Admin., supra note 19.

[22] 21 U.S.C. § 360bbb-3(b)(3).

[23] U.S. Food & Drug Admin., supra note 15, at 2.

[24] U.S. Food & Drug Admin., supra note 16, at 2.

[25] U.S. Food & Drug Admin., supra note 15, at 7-8.  (For timing purposes, the implementation date is set to occur at least 45 days after finalization of the guidance and the withdrawal date would occur 180 days after the implementation date.)

[28] U.S. Food & Drug Admin., supra note 16 at 5.

[29] See U.S. Food & Drug Admin., supra note 15, at 10-11 and U.S. Food & Drug Admin., supra note 16, at 11-12.

[30] See U.S. Food & Drug Admin., supra note 16, at 12.

[31] U.S. Food & Drug Admin., Refuse to Accept Policy for 510(k)s. Guidance for Industry and Food and Drug Administration Staff (April 21, 2022), https://www.fda.gov/media/83888/download, (Under this policy, the FDA reviews and informs the entity submitting the 510(k) within 15 calendar days if the submission does not meet the acceptance criteria).

[32] U.S. Food & Drug Admin., Acceptance and Filing Reviews for Premarket Approval Applications (PMAs). Guidance for Industry and Food and Drug Administration Staff (Dec. 2019), https://www.fda.gov/media/83408/download, (Acceptance and filing reviews are intended to determine whether the application submitted by the interested party is complete from an administrative standpoint).

[33] U.S. Food & Drug Admin., Acceptance Review for De Novo Classification Requests. Guidance for Industry and Food and Drug Administration Staff (Oct. 5, 2021), https://www.fda.gov/media/152657/download, (The De Novo classification option is an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a “not substantially equivalent” (NSE) determination in response to a premarket notification (510(k)) submission).

[34] See U.S. Food & Drug Admin., supra note 15, at 14-16 and U.S. Food & Drug Admin., supra note, 16 at 9-12.

[35] See U.S. Food & Drug Admin., supra note 16, at 11.

[38] U.S. Food & Drug Admin., Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Guidance for Industry and Food and Drug Administration Staff (Jan. 6, 2021), https://www.fda.gov/media/114034/download.

Top Pharmacology Researcher to Oversee School of Medicine’s Pioneering Biomedical Research

Top Pharmacology Researcher to Oversee School of Medicine’s Pioneering Biomedical Research

The School of Medicine has named Jeffrey R. Martens, PhD, as the new Senior Associate Dean for Research.

The University of Virginia School of Medicine has named Jeffrey R. Martens, PhD, an internationally recognized pharmacology researcher, leader, and educator, as the new Senior Associate Dean for Research. Martens will assume his new role on May 15, 2023. 

“Professor Martens will be a key contributor in the transformation of the School of Medicine and UVA Health medical research program, while also managing a rapidly growing portfolio of resources, innovative projects, and talent for the School of Medicine and the greater University,” said Melina R. Kibbe, MD, the dean of the UVA School of Medicine and chief health affairs officer for UVA Health.

Martens comes to UVA from the University of Florida College of Medicine, where he has served as chair of the Department of Pharmacology and Therapeutics for the past eight years. He has driven a 10-fold increase in outside research funding during his tenure. He also spearheaded collaboration within the College of Medicine as well as with research centers and institutes across the University of Florida. In addition, the academic and scientific achievements of his faculty resulted in U.S. News & World Report ranking for Pharmacology and Toxicology at UF in the top 17 nationally, the top nine among public universities and 50th internationally.

The impact of Martens’ research is demonstrated through his long list of peer-reviewed publications and the fact that his research has been continuously funded by the National Institutes of Health, National Science Foundation and the American Heart Association, among others, since 1990. Dr. Martens’ research is focused in two areas of pharmacology and therapeutics, including sensory neuropharmacology and cardiovascular pharmacology, with work in both the heart and olfactory systems.

Martens holds longstanding memberships in several professional societies, including the American Society for Pharmacology and Experimental Therapeutics and the Association of Chemoreception Sciences. He also has served in several editorial board positions for scientific publications, most recently as an editorial advisory board member for Molecular Pharmacology.

Martens earned his bachelor’s degree and doctorate from the University of Florida and did his post-doctoral training at Colorado State University. Before joining the faculty at the University of Florida, Martens was a faculty member at Oregon Health & Science University and the University of Michigan.

“This position at UVA is a new and different opportunity to lead across department boundaries and integrate the School of Medicine’s excellent clinical, translational and basic science efforts,” Martens said. “I am excited to collaborate with the School of Medicine’s world-class faculty and join a respected leadership team at a time of transformational growth.”

He succeeds Linda Duska, MD, MPH, who has served as interim Senior Associate Dean for Research since March 15, 2021. “The strategic guidance, leadership and program oversight Dr. Duska has provided to the School of Medicine has been invaluable,” Kibbe said. “I have extraordinary gratitude for her dedication and commitment to the School of Medicine and UVA Health.”

Duska will continue in her roles as Associate Dean for Clinical Research in the School of Medicine, Vice Chair for Research in the Department of Obstetrics and Gynecology, and as a gynecologic oncologist at the UVA Cancer Center.

Vermont’s largest health care union will almost double in size

Vermont’s largest health care union will almost double in size
Members of the support staff at the University of Vermont Medical Center in Burlington celebrate after they voted to unionize on Friday, Jan. 27. Photo by Glenn Russell/VTDigger

Support and technical staff employed by the University of Vermont Medical Center voted overwhelmingly this week to unionize, joining the hospital’s nurses and other technicians as part of the Vermont Federation of Nurses and Health Professionals. 

More than 1,300 people participated in the voting, which was run by representatives of the National Labor Relations Board over three days at the UVM Medical Center’s main campus and in a cafeteria at the Fanny Allen campus. The vote results, 997-163 for support staff and 123-18 for technical staff, were announced by the union late Friday afternoon.

“The energy in the building is very excited,” said Jacob Berkowitz, a member of the 70-person union organizing committee and a staffing office specialist at the hospital. After 11 months of effort to organize, “to finally have that union and to win in such a strong fashion, it feels great,” he said.

As a result of both votes, the Vermont Federation of Nurses and Health Professionals, already the state’s largest affiliation representing some 2,500 health care workers, will roughly double in size by bringing 2,200 more support staff under representation. The union is an affiliate of the national American Federation of Teachers, or AFT, an arm of the AFL-CIO, one of the nation’s longest-standing labor organizations, which called it “likely the largest private-sector election in Vermont ever.”

Support staff from a wide variety of categories will participate in a new bargaining unit that will include licensed nursing assistants, lab and office assistants, phlebotomists, food service, custodial workers, schedulers and parking attendants. It will encompass workers from both the hospital and more than a dozen outpatient offices, including family medicine, dental, ophthalmology and orthopedic care, among others. 

A separate vote added mental health workers from the emergency and psychiatry departments, as well as pharmacy and laboratory technicians, to the existing technical staff bargaining unit. 

Deb Snell, president of Vermont Federation of Nurses and Health Professionals union at the University of Vermont Medical Center in Burlington, speaks afte hospital staff voted to unionize on Friday, Jan. 27. Photo by Glenn Russell/VTDigger

Organizing across so many different departments and facilities made the effort difficult, but also rewarding, and ensured members came from all walks of life and included people from many different racial and ethnic groups, Berkowitz said. 

The process of building the union through many hours together outside of work brought them closer and has created a real sense of community, said Natalie Cartier, a pharmacy technician. “I see so many people now, just passing them in the hall, and know we have each other’s best interests at heart,” she said. “We all have each other’s back.”

The result of the two votes also has symbolic significance for worker representation in general, organizers said. UVM Medical Center is the state’s largest employer with 8,800 employees, more than half of whom will now be represented by the same union organization. 

Stephen Leffler, UVM Medical Center president and CEO, said in an emailed statement that the organization “is committed to a culture where our people feel heard, respected and supported.” 

“We believe the election administered on-site by the National Labor Relations Board met that goal, and expect to be in contact with the union soon to begin negotiating in good faith a collective bargaining agreement,” he wrote.

Unionization has heated up at UVM Medical Center in recent years. Medical residents voted to form their own union, which has been active in seeking better pay and working conditions for its members. Nurses went on strike in 2018 during contract negotiations, and successfully bargained for a mid-contract wage increase last year. 

AFT Vermont also represents health care workers at Brattleboro Memorial Hospital and the Community Health Centers of Burlington. A regional independent union, United Nurses and Allied Professionals, represents nurses and other health care workers at other hospitals in the state, including Copley Hospital in Morrisville, Springfield Hospital and the Brattleboro Retreat. 

Union membership nationwide fell to a new low last year, making up just 10.1{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of workers, according to new 2022 figures out last week from a survey done annually by the U.S. Department of Labor. Thirty years ago, that percentage was more than 20{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}. 

Just over 12{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of Vermont workers are union members, according to the survey. The percentage is slightly higher among health care practitioners and affiliated technical workers nationwide at 13{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}, but is lower among health care support workers, at 9.3{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}

Both Berkowitz and Cartier said they have been inspired by the passion and work ethic that their colleagues bring to their jobs each day, and they want to see that recognized. “We absolutely are the backbone of the hospital,” Cartier said.

The new bargaining unit will also be seeking better wages, specifically a minimum wage of at least $20 per hour. “Bottom line, that is the living wage in this county and in this state,” said Berkowitz. “It is imperative to get that for people who are working so hard, and who are so patient-facing.”

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10 Best Pre-Workout Supplements for Women, According to Experts

There are hundreds, if not thousands, of pre workouts for women on the market all proclaiming to maximize your performance and results. But given that the supplement industry isn’t closely regulated, it can be hard to decide which supplements are worthwhile. The good news is, there is science to back that certain ingredients can, in fact, boost performance, but even so, they’e not necessary for every person or workout. “There are countless types of pre workout supplement options available, and what’s in them varies. They’re not necessary for everyone, particularly not for people engaging in lower-intensity workouts,” says Jordan Hill, M.C.D., R.D., C.S.S.D., a registered dietitian with Top Nutrition Coaching.

If you’re working toward a specific fitness goal, like increasing muscle mass, or completing an athletic event, pre workout may help give you a boost during your workouts to help you get there. That said, Hill emphasizes that supplements should always be used as supplements to a well-rounded diet, and not a replacement for a well-balanced diet. “Without proper nutrition—balanced meals and appropriate timing—supplements won’t deliver results to their full potential. It’s important to have food as the foundation and then you can bring in supplements to augment what you’re already getting through food,” she says.

Hill points to caffeine, creatine, beta-alanine, BCAAs (branched-chain amino acids), nitric acid precursors including L-citrulline and nitrates as common, science-backed ingredients. And while many supplements are specifically marketed to women, you shouldn’t feel limited to selecting pre workouts for women because there’s not much research available to distinguish what supplements might be better suited for a woman or a man. “The majority of supplement research (and sports nutrition research, in general) has been done with male subjects,” Hill says. “More research would be needed to define any potential differences in the pre-workout needs of women versus men.” In other words, if you find a pre workout you love, and it’s geared to guys? Don’t sweat it. Or rather, do sweat it—enjoy the supplement and reap the benefits it offers.

Meet the Experts: Jordan Hill, M.C.D., R.D., C.S.S.D., is a registered dietitian and nutrition coach with Top Nutrition Coaching. Mary Wirtz, M.S., R.D.N., C.S.S.D., is a registered dietitian and consultant to Mom Loves Best.

Our top picks

Based on feedback from our experts and confirmation from third-party testing organizations, consider picking up one of the following best pre workouts for women.

Dietary supplements are products intended to supplement the diet. They are not medicines and are not intended to treat, diagnose, mitigate, prevent, or cure diseases. Be cautious about taking dietary supplements if you are pregnant or nursing. Also, be careful about giving supplements to a child, unless recommended by their healthcare provider.

Regulatory Horizons Council report on medical devices: government response

Executive summary

The Regulatory Horizons Council (RHC) report on medical devices comes at an opportune time. Following the UK’s withdrawal from the EU and the Medicines and Healthcare products Regulatory Authority’s (MHRA) consultation on the future regulation of medical devices, the government is well placed to take forward the report’s recommendations and deliver a world-leading regulatory framework.

This response addresses the report’s recommendations in 4 key areas:

1. Patient outcomes and safety

By building greater patient engagement into the regulatory framework and enhancing the reporting of safety risks, we will ensure a system that is centred on the needs and safety of patients.

2. International leadership and engagement

Positioning the MHRA as a world-leading regulator, the new framework will expand international engagement and establish the UK as a pioneer in the regulation of emerging technology, including software as a medical device and in-vitro diagnostics (IVD).

3. Investment in regulatory capacity

We will maximise the opportunities offered by the transition to UK Conformity Assessed (UKCA) marking – not only increasing the number of UK approved bodies to meet capacity, but also exploring opportunities to increase UK-based regulatory expertise.

4. Unlocking innovation and emerging technology

The MHRA is committed to supporting responsible innovation while minimising risk to patients and the public. Across government, we will continue to explore pathways to bring the most transformative emerging technologies to market and to the NHS, and attract investment in innovative devices.

Introduction

The RHC is an independent expert committee that identifies the implications of technological innovation, and provides government with impartial, expert advice on the regulatory reform required to support its rapid and safe introduction. The RHC is supported by civil servants from the Better Regulation Executive (BRE) in the Department for Business, Energy and Industrial Strategy (BEIS)

The RHC published its report on medical devices on 19 August 2021, in response to rising complexity of medical technology and the opportunities for global leadership that EU exit has enabled. It sought to answer the following question: ‘How can the UK encourage international investment and innovation and improve safety in the medical devices area through regulatory and non-regulatory changes?’. The RHC engaged with industry experts and across government, and commissioned evidence.

The government has considered each of the report’s 11 recommendations and this response focusses on the actions being taken in response.

This response builds on the government’s response to the MHRA’s consultation on the future regulation of medical devices, published on 26 June 2022, which confirms the direction of travel for medical devices regulation in the UK. Having left the EU, we have been given a substantive opportunity to update and improve the UK’s medical devices regulatory landscape, supporting the growth of the UK life sciences sector. Full details of the future regulatory framework for medical devices can be found in the government’s response and appropriate references are included in this document.

Summary of the government response to each of the report’s recommendations

Building a regulatory system for medical devices that works for patients

Recommendation 1

The regulation of medical devices should be centred on the needs of patients, informed by patients, record outcomes that matter to patients, and provide evaluations that are understandable to patients.

Government response – accept

The government recognises and supports the MHRA’s delivery plan 2021 to 2023 Putting patients first: a new era for our agency, which sets out the MHRA’s roadmap for the future, centred on better public and patient involvement throughout their work.

This delivery plan has initiated a substantial programme of work to:

  • improve how it listens and responds to patients and the public
  • develop a more responsive system for reporting adverse incidents
  • strengthen the evidence to support timely and robust decisions that protect patient safety

This emphasis has already had an impact on how the MHRA works with patients in tangible ways. For example, the MHRA actively engaged with patient representatives in the development of the policies for the future regulatory framework for medical devices, during the public consultation that ran in autumn 2021, with over 300 attendees joining a public engagement session in October 2021.

The MHRA will continue to actively engage stakeholders, including patient representatives, in a series of planned focus groups. The focus groups will commence in January 2023 and will meet regularly to provide guidance around the chapters of the government response. A series of one-to-one meetings with patient representatives is also planned and will feed into all focus groups to gather patient input across a total of 20 topics for the guidance and other support materials necessary to aid transition to the amended regulatory system.

The government will continue to monitor the impact of the MHRA’s delivery plan and ensure that patient-centred regulation becomes embedded in the MHRA’s ways of working.

Increasing capacity to address present needs and emerging opportunities

Recommendation 2

Strengthen and increase funding to the MHRA to significantly expand their capacity in medical devices, including in emerging technologies.

Government response – accept in principle

The government continues to support the appropriate funding required for the operation of the MHRA, taking into account all of its functions. The MHRA’s regulatory functions for medical devices are primarily funded by the Department of Health and Social Care (DHSC), with the remaining revenue from fees charged for services.

In August 2022, the MHRA launched a consultation on proposals for changes to their statutory fees. The proposals are intended to ensure the MHRA is adequately resourced, including in areas of technological progress in medical devices where increased resource is required.

Recommendation 3

Address bottlenecks in the approval of medical devices, notably the shortage of UK approved bodies for conformity assessment.

Government response – accept

The MHRA focuses on ensuring conformity assessments are carried out consistently and robustly by UK approved bodies (ABs), which must effectively assess medical devices to assure their safety, quality and performance. View a list of UK approved bodies for medical devices.

The MHRA is currently reviewing several applications from organisations that have applied for designation as a UK approved body (AB). The MHRA is also actively working with organisations that are preparing to apply for UK AB designation either through new applications or extending their existing scope for conformity assessment.

Further information on mitigations for bottlenecks in the approval of medical devices is detailed in the response to recommendation 4 below.

Recommendation 4

Prepare mitigations that supplement AB capacity to ensure supply of devices after transition to UKCA.

Government response – accept

The MHRA has been exploring options to mitigate AB capacity issues, and will continue to communicate with industry for views to ensure there is a smooth transition to any regulatory changes, recognising that the medical devices sector requires time to make changes.

To address anticipated challenges relating to AB capacity, the future regulatory framework for medical devices will set out the government’s plans for a phased introduction of the proposed requirements to ensure there is a considered approach to implementation. This will allow manufacturers to leverage certification under the existing UKCA and CE marking processes.

Devices that are UKCA marked under the existing UK regulations prior to the new regime taking effect will be permitted to continue to be placed onto the GB market for 3 years for general medical devices and 5 years for in-vitro diagnostic (IVD) medical devices or until their current certifications expire, whichever is sooner. This will allow for the upscaling of the approved body capacity.

Devices that are CE marked under EU legislation will be permitted similar transition timescales and these will run from 1 July 2024, when the new regime is planned to come into effect. For devices CE marked under the EU directives (former EU legislation), these timescales will be 5 years for IVD medical devices and 3 years for other medical devices, or until their certifications have expired, whichever is sooner. For devices CE marked under the new EU regulations (EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)), it will be permitted to place these devices onto the GB market for up to 5 years from 1 July 2024.

It is not anticipated that an extension of this provision will be required, as the intervening period will be used to support an increase in AB capacity to ensure the UK has sufficient capacity to transition all medical devices to the UKCA marking system. The MHRA will also be working to build the UKCA marking for medical devices on a global standing.

These approaches have been designed specifically to alleviate pressure on ABs, given current capacity restraints. The phased implementation of the new regime has also been developed to prioritise patient safety and minimise the risk of critical supply issues, ensuring the continued safe supply of medical devices to the UK market.

International leadership and partnership in medical devices

Recommendation 5

Support the MHRA to increase UK visibility, international engagement and leadership.

Government response – accept

The government’s response to the MHRA’s consultation outlines the future regulatory framework for medical devices, which includes proposed changes that will position the MHRA as a world-leading regulator.

The future regulatory framework will be unique, innovative and ambitious in areas such as software as a medical device, artificial intelligence as a medical device, and IVDs, while maintaining a focus on patient safety. This leading regulatory model will put the MHRA in a leadership position among international peers in addressing challenges such as proportionate regulation of software as a medical device, ensuring that the UK attracts a world-class life sciences industry. Through the coronavirus (COVID-19) pandemic, the MHRA has shown itself to be one of the world’s foremost regulators – and true innovators.

The MHRA has recently gained full membership of the International Medical Devices Regulators Forum (IMDRF), a group of 10 regulatory authorities focussing on accelerating international medical device regulatory convergence. As a full IMDRF member, the MHRA will be able to take a greater international role in promoting an efficient and effective regulatory model for medical devices, responding to emerging challenges while protecting and maximising public health and patient safety.

The MHRA is also an official observer of the Medical Device Single Audit Programme (MDSAP). MDSAP is a way in which manufacturers can seek a single assessment of conformity of their quality management systems against the regulatory requirements for any of the 5 full member states: Australia, Brazil, Canada, Japan and the US.

More specifically, the MHRA has worked with the US Food and Drug Administration (FDA) and Health Canada to publish an agreed list of 10 Good Machine Learning Practice Principles (October 2021). This document is intended to ensure aligned thinking between the regulators and is the first step of collaborative work in this area between regulators. Building on this collaboration, the MHRA continues to strengthen their relations and are working together to deliver further documents to ensure internationally aligned thinking on artificial intelligence (AI) and machine learning-enabled medical devices. In addition, through participation of the IMDRF, the MHRA is developing AI-specific guidance that will set the global standards for regulatory compliance.

More widely, the MHRA has collaborated with the NHS Transformation Directorate on the G7 health track digital health proposal on AI governance as part of the UK delegation (paragraphs 40 and 41, G7 Health Ministers Declaration). Through this work we are contributing to the international dialogue on digital health and providing recommendations on how countries can work together to ensure their citizens can benefit from digital health technologies.

The MHRA is working closely with the British Standards Institute (BSI) in its roles as the UK national standards body and a global standards promoter in partnership with their US counterpart, the Association for the Advancement of Medical Instrumentation (AAMI). The MHRA contributes to several standards committees in this space, namely: BS30440 Validation Framework for the use of AI in Health and Care, and Committees: CH/62/2 Diagnostic Imaging Equipment, CH/62/3 Equipment for Radiotherapy, Nuclear Medicine and Radiation Dosimetry, and IST/35 Health Informatics. Additionally, the MHRA also provides input on many of the major reporting guideline variants for AI, such as CONSORT-AI, SPIRIT-AI, and DECIDE-AI, increasing the MHRA’s international engagement and leadership in developing regulatory guidelines.

This international work is a key component in ensuring alignment and the long-term success of MHRA’s domestic legislative and regulatory guidance plans for the future regulation of software as a medical device (SaMD) and artificial intelligence as a medical device (AIaMD).

Recommendation 6

Invest in the UK as a global centre for regulatory science and the training of regulatory professionals with expertise in medical devices, including in emerging technologies.

Government response – accept in principle

The government’s current focus for medical devices is to implement changes to the regulatory framework that increase patient safety and promote innovation, thereby growing the life sciences sector in the UK. Alongside this, we are interested in the opportunities posed by a UK centre of excellence in regulatory science and innovation (CERSI). This was also a recommendation of the Taskforce on Innovation, Growth and Regulatory Reform report 2021, and we will continue to work with stakeholders to explore options for this.

While the activities related to the future medical devices regulations do not bring additional direct investment, they do provide a robust and positive environment in which the UK can build its reputation in all areas of life sciences, and in particular a supportive UK regulatory environment for the safe and rapid development of innovative medical devices.

In addition to the new regulatory framework, the government’s ambition to ensure the UK is a leading global hub for all aspects of life sciences is being driven by the Life Sciences Vision, published by the Office for Life Sciences in July 2021. On skills, the vision makes commitments to:

  • welcoming and advocating the free flow of life sciences talent globally, underpinned by the UK’s new immigration system
  • boosting the proportion of the apprenticeship levy recovered by the life sciences sector
  • building links between life sciences university courses and industry
  • exploring how the sector can effectively meet emerging skills demands

The vision also sets out its aims to deliver a progressive UK regulatory offer with the capacity to unleash innovation in regulatory processes. This includes a specific funding allocation to the MHRA and the National Institute for Health and Care Excellence (NICE) to develop a new access and licensing pathway for medical devices, similar to that which exists for medicines.

To further support this work, the MHRA’s future regulatory framework for medical devices will actively address the safety and availability of medical devices, and the favourability of the UK as a place to research, develop, manufacture and supply medical devices. The government has outlined intentions for requirements for a Qualified Person within the response to the MHRA’s consultation on the regulatory changes for medical devices. This proposal will require that manufacturers have available within their organisation (or in the case of small and medium-sized enterprises (SMEs), at their disposal) at least one Qualified Person with qualifications or regulatory experience that meets minimum standards that would be set out in the UK medical devices regulations in the field of medical devices and IVDs. This commitment will provide a strong incentive for increased training of regulatory professionals with expertise in medical devices.

Recommendation 7

Build international partnership through mutual recognition and reliance or assurance where this may lead to overall efficiencies while preserving safety.

Government response – accept

The MHRA delivery plan 2021 to 2023 outlines commitments to building excellent international relationships that:

  • deliver high standards of patient protection
  • prompt access to innovation products
  • keep the UK as an attractive market for developers and manufacturers

The government sees international partnership as vital to deepen co-operation, exchange information and encourage the adoption of international standards and best practice.

The government also intends to use both certificates from the Medical Device Single Audit Program (MDSAP) and domestic assurance as alternative routes to market in the UK, which will make it easier for manufacturers to bring medical devices to the UK market while retaining strong regulatory oversight of their safety and performance.

The UK will require UK approved bodies to consider MDSAP assessments. However, adoption will be optional for manufacturers. Domestic assurance routes will allow an abridged assessment with the appropriate scrutiny, and UK approved bodies will hold the capacity to reject applications under the domestic assurance route if they do not consider the evidence provided to be sufficiently robust to undergo assessment through this route.

In 2019, the UK signed a mutual recognition agreement (MRA) with Australia that contains conditions under which each country will accept conformity assessment results from the other. This means that UK goods can be tested in the UK against Australia’s regulations, and then sold in the respective country without additional testing. This also applies for goods tested in Australia to the UK regulations.

We are in ongoing discussions to expand existing MRAs to include medical devices, and to build new MRAs that provide for a mutual acceptance of conformity assessment results with other countries. The UK-Canada Trade Continuity Agreement highlighted that the medical devices sector is a priority for mutual recognition of the acceptance of conformity assessment results, and further expansion will be explored in the future.

Through bilateral engagement, the government is encouraging other countries to join and adhere to multilateral medical device regulatory forums, which produce best practice guidelines for regulators and reduce the discrepancies between regulatory systems. Through further international collaboration and regulatory harmonisation, we will promote an efficient and effective global market for placing medical devices on the market, which is responsive to emerging challenges while maximising patient safety.

Using medical devices as a template to help enable regulatory innovation that improves patient safety, system efficiency and UK growth

Recommendation 8

Identify and resource areas where regulatory innovation within the medical device sector may attract inward investment and growth.

Government response – accept

The MHRA’s future regulatory framework outlines plans to create new routes to market to support innovation in medical devices. This will ensure the UK remains an excellent place to launch new medical devices and avoid repeat assessments, while maintaining robust safety standards.

Following the UK’s departure from the European Union, the MHRA now has direct responsibility for the regulation of medical devices in the UK. One of the freedoms that come with this is the ability to reform medical device regulation to ensure it better fits software and AI.

The regulation of AIaMD is an area where regulatory innovation will attract inward growth and investment. The MHRA has an opportunity to become a global leader in the regulation of AIaMD and to demonstrate the MHRA’s capacity to support responsible innovation while minimising risk to patients and the public.

The MHRA has embarked upon an ambitious Software and AIaMD Change Programme to help achieve this, reforming medical devices regulation as it applies to software and AI, and introducing new guidance and support packages. This work programme will deliver bold change to bring a high degree of protection for patients and the public, while also making sure that the UK is the home of responsible innovation for medical device software.

As mentioned in the response to recommendation 6 above, the MHRA and NICE also have plans to establish a pathway for medical devices that is similar to the Innovative Licensing Access Pathway that is currently in place for medicines. This pathway will allow for increased MHRA and NICE support for products that meet a critical unmet need, thereby attracting growth and investment in this sector.

To further explore pathways for innovative devices, the government is working to explore options to increase access and adoption of medical technologies. This will accelerate the work already in motion as part of the Life Sciences Vision, the MHRA’s new regulatory framework and the upcoming MedTech strategy by finding opportunities to increase market access and adoption of medical technology. As a result, we will seek to increase investment by making the UK a more attractive regulatory environment for companies bringing new products to market.

Recommendation 9

Develop a UK patient safety database that collects key details of all medical devices and monitors patient safety and wellbeing moving forward.

Recommendation 9A

Strengthen existing safety reporting through digital tools and the use of comprehensive data collection from health systems, patients and carers to a central MHRA-held UK patient safety database.

Recommendation 9B

When medical devices are used, their unique device identifier (UDI) should be recorded as standard within a patient’s health record, and this should be returned to a central MHRA-led UK patient safety database.

Government response – accept in principle

The MHRA has recently launched improvements to its Yellow Card scheme, which collects and monitors information from the public on suspected safety concerns involving healthcare products, including medical devices. The scheme helps the MHRA monitor the safety of medical devices along with all healthcare products in the UK, and reports through the scheme are used to help the MHRA identify any trends in the safety or efficacy of a medical device and take action accordingly.

The scheme’s improved website went live on 7 February 2022 with new functionality for reporters, such as a single reporting form, and further enhancements to the reporting journey will be made in coming months. One technology platform for incident management and signal detection across medicines and devices is being developed for the MHRA’s use, which will allow improved analysis and faster signal detection, and enable the MHRA to proactively respond to safety concerns.

Another key focus of current work in improving the safety of patients using medical devices is in the area of implantable devices. Following several high-profile failures of implanted medical devices, the government has recognised the need for greater, systematic information to be captured and shared on these interventions. The need for better data on patient outcomes and device traceability was highlighted by the Independent Medicines and Medical Devices Safety (IMMDS) Review, which recommended a system be established that would capture key information on implanted devices at the time of the operation and linked to specifically created registers to research and audit the outcomes both in terms of device safety and patient-reported outcome measures. The government accepted that recommendation in its response to the IMMDS Review on 21 July 2021.

In 2021 to 2022, a scoping exercise was undertaken that provided substantial learnings for how best to deliver on these traceability and patient outcome objectives. The government sets out more detail on how this work is progressing in the IMMDS implementation update. It is envisaged that the data collected as part of this programme will be shared with the MHRA for post-market surveillance purposes and therefore we do not accept that part of the recommendation.

Building resilience and preparing for future threats

Recommendation 10

Pandemic preparedness should include fast-track evaluation of new IVDs.

Government response – accept

The MHRA’s future regulatory framework intends to reform IVD regulation to update classification and include an extended patient risk review, recognising the central role that diagnostic devices have played in our response to the COVID-19 pandemic.

While stronger regulation is needed, the diagnostics sector needs to be sufficiently responsive. The 100 Days Mission to Respond to Future Pandemic Threats (June 2021), announced at the G7 Summit in Cornwall – proposed to build a framework for fast pandemic threat response and related work – will be taken forward through this strand. This framework will include plans for enabling prioritisation of clinical trials for diagnostic products (as well as vaccines and therapeutics) and faster approvals from regulators.

The 100 Days Mission for diagnostics, therapeutics and vaccines was welcomed by G7 and G20 leaders respectively. The first implementation report was published by the G7 Chief Scientific Advisers in December 2021, which outlined progress to date and a roadmap for achieving the mission by 2026. As part of the 100 Days Mission, the MHRA and the US FDA will collaborate with their G7 counterparts to implement proposals to streamline regulatory processes over 2022 to 2026. This could include a streamlined process for new product applications, and will explore the possibility of reciprocal agreements on regulatory approval to negate the need for the same product to be approved in multiple jurisdictions.

The lessons from the COVID-19 pandemic are being considered, and the government intends to enable a fast-track route for IVDs, as part of the ambition outlined in the 100 Days Mission, that is proportionate and workable for industry should future threats emerge, while maintaining quality and performance.

Recommendation 11

Reporting of diagnostic tests should be transparent and standardised.

Government response – accept in principle

The MHRA’s future regulatory framework intends to address the recommendation to increase the level of scrutiny applied to IVD devices. The new framework for IVDs will amend the classification rules to increase the level of scrutiny applied to IVDs. This will mean a higher proportion of IVDs will undergo an assessment by a UK approved body prior to being placed on the UK market. The proposed regulatory changes will take into account the intended purpose of the medical device and will reflect relevant international systems of regulation, driving greater patient safety.

The new regulatory framework will bring significant improvements in patient safety and ensure more robust pre and post-market requirements are introduced for IVDs, aligning with the international set of standards set by the IMDRF, rather than the Standards for Reporting of Diagnostic Accuracy Studies Framework. This will provide clarity and ensure that performance studies for IVDs are carried out in a consistent way. The government aims to set out in detail the specific requirements for any performance study, and to publish detailed guidance to accompany the regulatory requirements.