CDRH Looks Towards the End of the Public Health Emergency and Transition for EUA and Devices Marketed Under Enforcement Discretion

In late December, as cases of Omicron were soaring, CDRH issued two draft guidance documents to prepare for the end of the public health emergency.  The pair of draft guidances laid out the transition for devices that are being marketed under an EUA and devices being marketed subject to enforcement discretion policies.  Copies of the guidances can be found here and here.

Below we discuss the transition plan for each of the types of devices.  At a high level, FDA will be allowing manufacturers a period of no less than 180 days to submit a premarket submission for devices marketed under an EUA or an enforcement policy.

Devices Marketed Under an Enforcement Policy

The draft guidance proposes a 180-day transition period from the implantation date (the “Transition Period”) for devices marketed under the enforcement discretion policies identified specifically in the draft guidance. Once FDA finalizes the guidance, it will identify the implementation date, which will be at least 45 days after the date of the final guidance. At the end of the Transition Period, FDA intends to withdraw the enforcement policies identified in the draft guidance.

The Transition Period will consist of three phases:

• Phase 1: Begins on the implementation date and will require manufacturers to comply with the requirements of 21 C.F.R. Part 803 (MDR reporting) for these devices;
• Phase 2: Begins 90-days after the implementation date and will require manufacturers intending to continue marketing of its devices after the Transition Period to:
  • Comply with the requirements of 21 C.F.R. Part 806 (corrections and removals);
  • Register and list with FDA pursuant to 21 C.F.R. Part 807 (note: listing can be completed without yet having a premarket submission number); and
  • FDA recommends that manufacturers of certain life-supporting and life-sustaining devices submit a “Notification of Intent” to FDA (as described in the guidance);
• Phase 3: Begins 180-days after the implementation date and will require:
  • Manufacturers not planning to continue marketing after withdrawal of the guidances to cease commercialization on or before this date; or
  • Manufacturers planning to continue commercial distribution to submit a premarket submission (e.g., 510(k), de novo) and have it accepted (i.e., through the refuse to accept process).

The draft guidance recommends that premarket submissions for these devices include a transition plan.  The details of which are described in the draft guidance.  For manufacturers that have an accepted premarket submission under review at the start of Phase 3, FDA does not intend to object to continued distribution of the devices until a final decision is made by the Agency on the submission.  How long a submission may remain under review is not clear.  At this time, FDA is continuing to grant applicants an automatic 360 days to respond to requests for additional information pursuant to its Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers (Revised) (June 2020).  We have asked CDRH but not gotten a response as to how long this policy will remain in place.  It will be a huge difference for sponsors if they have effectively 12 months to respond to a request for additional information as compared to six months.  We urge FDA to clarify the relationship of this policy and the proposed transition plan in the final guidance.

The guidance provides additional details on how manufacturers who intend to cease distribution should disposition their devices.

Devices Marketed Under an EUA

FDA anticipates that it will publish in the Federal Register notice a date for termination of the EUA declaration (the “EUA Termination Date”).  The draft guidance states that the federal register notice will occur at least 180 days prior to the EUA Termination Date.  The draft guidance proposes allowing manufacturers to continue commercializing devices subject to an EUA so long as they submit a premarket submission and have it accepted prior to the EUA Termination Date.

In terms of when the EUA Termination Date will occur, it is important to remember that there are three separate emergency declarations, which could end at different times to trigger this transition for the applicable device types.  There are emergency declarations for (1) in vitro diagnostic devices for COVID; (2) personal respiratory protective devices; and (3) for other medical devices due to shortages.  These declarations could end at the same or different times thereby potentially creating different EUA Termination Dates for different device types.

The draft guidance recommends that manufacturers of certain life-supporting and life-sustaining devices (identified in the draft guidance) with approved EUAs notify FDA as soon as possible after this guidance is finalized whether or not they intend to continue marketing their device.  The content of the proposed notification is outlined in the draft guidance.

FDA recommends that the premarket submission for devices subject to an EUA include a “transition implementation plan” that addresses devices already in the field in the event of a positive or negative decision on the submission.

Until the end of the Public Health Emergency, FDA will continue to accept and review EUAs.

Last week, CDRH held a webinar to discuss the guidance documents.  There were many questions from industry—some could be answered and others couldn’t.  For example, there were numerous questions related to in vitro diagnostics and laboratory developed tests for COVID.  FDA did not answer any of those questions and referred the audience to the weekly COVID IVD townhalls held on Wednesdays.  The Agency did state that it was willing to consider postmarket data in submissions for these devices and urged sponsors to discuss its submission plans and data with it via the pre-submission process.

In our view, while the draft guidances are a reasonable start, they lack specificity for a number of device-specific issues.  Manufacturers will want to review the draft guidances carefully and reach out to CDRH if you have specific questions (DICE@fda.hhs.gov).

FDA is accepting comments on the draft guidances through March 23, 2022.  We have certainly heard from industry that there are those that think the proposed transition periods are both too short and too long.  It will be interesting to see what the final guidances look like.