FDA Details Post-COVID Transition Guidelines for EUA Devices

In February 2020, the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to certain medical devices needed to address the challenges imposed by the COVID-19 virus.¹ Seeing the possibility of a light at the end of the tunnel, the FDA has begun making preparations for med device companies to return to normal regulatory processes after the EUA status of their devices expires.

Last month, the FDA’s Center for Devices and Radiological Health (CDRH) hosted a webinar through CDRH Learn. During the FDA’s online training, the agency provided details about two new guidances it has drafted, which explain how med device manufacturers should plan to transition away from EUA.

In short, the agency is proposing to give medical device makers advanced notice of 180 days before terminating the company’s EUA status and replacing its enforcement policies for medical devices issued during the COVID-19 public health emergency (PHE).

During this advanced-notice timeline, med device companies have two options:

• Discontinue distributing their EUA-authorized devices.
• Seek permanent marketing authorization for their devices.

EUA Transition Guidances

In laying the groundwork for the transition, the agency created two guidances outlining the transition policies to ensure a smooth transition to normal operations and to avoid supply disruptions. The public-comment cutoff date for the guidances was March 23, 2022:²

Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus 2019 (COVID-19) Public Health Emergency

This guidance instructs the manufacturers of devices that were issued EUAs on how to make the transition after their EUA has expired. This guidance does not apply to:

• Devices with EUAs that the FDA chooses to revoke because the section 564(c) criteria are no longer met or due to circumstances where revocation is appropriate to protect public health or safety.
• 564A current good manufacturing practice (cGMP) deviations.

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus 2019 (COVID-19) Public Health Emergency

This guidance applies to manufacturers of devices that fell within the enforcement policies. These devices were designed to support the emergency response to the COVID-19 PHE (i.e., COVID tests and personal protective equipment (PPE)). This type of approval also expands to the availability and remote monitoring capabilities of certain devices such as infusion pumps and non-invasive remote patient monitoring to reduce the risk of exposure for patients.

FDA Online Training for Medical Device Manufacturing

On February 22, 2022, the FDA’s online training included information for stakeholders interested in learning more about the guidances for medical devices. The webinar’s objectives were to:³

• Help prepare medical device manufacturers and other stakeholders for an orderly and transparent transition to normal regulated operations.
• Describe recommendations and timelines for marketing submissions.
• Explain the 180-day transition period.

The webinar featured Jacqueline Gertz, Ph.D., policy analyst, clinical and scientific policy staff, Office of Product Evaluation and Quality (OPEQ); Joshua Silverstein, Ph.D., policy analyst, regulation, policy, and guidance staff, OPEQ; and Eli Tomar, JD associate director, Office of Policy.

The webinar’s presenters explained that the plans are set up to foster an orderly transition path. The path for medical devices with EUAs and those under the enforcement policy are broken into the three phases explained below.

Note: The transition implementation date referred to in the phases is approximately 45 days after the finalization of the two guidances, which will occur at a later date.

• Phase one – Begins on the transition implementation date. Recommendations from the FDA to medical device manufacturers are to submit any adverse reports that were created and stored as required in 21 CFR Part 803. Also, they should prepare marketing submissions if they intend to continue distribution of the devices after the transition. Prior to phase two, the FDA suggests following 21 CFR Part 806 (reports of corrections and removals) and Part 807 subparts B-D (registration and listing).
• Phase two – Begins 90 days after the implementation date. Medical device manufacturers that intend to continue to distribute their devices after the transition should register their establishments and list their device(s) or update existing registration and listing (R&L). If applicable, the medical device manufacturer is expected to prepare to submit a marketing submission to the FDA and have it accepted before the start of phase three. This will allow the agency to best manage its resources for review of marketing submissions.
• Phase three – Begins 180 days after the implementation date. In the guidelines, the FDA says it intends to withdraw the enforcement policy guidance listed in the transition plan and that manufacturers will be expected to comply with all statutory and regulatory requirements applicable to their devices.

In the event the FDA finalizes the guidances before the PHE declaration expires, the 180-day transition would begin the date the PHE declaration expires. If the guidances for medical device manufacturers are finalized after the PHE declaration expires, FDA says it will announce an implementation date in the final guidances that is at least 45 days after the guidances are published.³

When Medical Device Distribution Discontinues After the EUA Transition

Certain devices not intended to be distributed after the PHE transition will have a different termination path depending on the type of device:³

• Single-use devices (SUDs), Non life-supporting (LS)/life sustaining (LS) – Devices will remain distributed and consumed.
• Reusable, non LS/LS – Devices will remain distributed and used if they are:
• Restored to a cleared/approved version.
• Have labeling publicly available that describes features and that the device lacks FDA clearance or approval.
• Reusable, LS/LS – Devices will remain distributed and used if they are:
• Restored to a cleared/approved version.
• Have labeling publicly available that describes features and that the device lacks FDA clearance or approval.
• In Vitro Diagnostics (IVD) under EUA – Devices will remain distributed for two years or until the expiration date, whichever comes first.

Final FDA Actions for Medical Device Manufacturing

The agency expects the distribution of medical devices under EUA and those within the enforcement policy to cease when:

• Marketing submission is not accepted by the 180-day transition period.
• There has been a negative decision on the marketing submission.
• The marketing submission has been withdrawn or fails to provide a complete response to request for additional information.

The FDA’s guidances for medical devices align with the agency’s top priorities of protecting the public’s health and safety. Still, the agency recognizes the importance of flexibility while facilitating the necessary regulatory oversight. The FDA also acknowledges that there are unique circumstances such as scenarios that are not addressed in the guidances. These situations need to be addressed individually with the agency on a case-by-case basis.

In the meantime, medical device manufacturers are expected to work toward submitting a marketing application within the set timelines. The FDA is willing to assist with this process, so companies may want to initiate discussions with the agency using the Q-Submission program.

References:

1. “Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices,” U.S. Food and Drug Administration (FDA), February 4, 2020.
2. “FDA Proposes 180-day Transition Before Terminating COVID-19 EUAs, Enforcement Policies,” Michael Mezher, Joanne S. Eglovitch, Regulatory Affairs Professionals Society (RAPS), Jan. 4, 2022.
3. “Webinar on Draft Guidances on Transition Plans for COVID-19-Related Medical Devices,” U.S. Food and Drug Administration (FDA), Feb. 22, 2022.