I. Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
As explained in the EUA policy draft guidance, Section 564 of the Federal Food Drug and Cosmetic Act (FDCA) authorizes FDA, after the HHS Secretary has made a declaration of emergency or threat justifying authorization of emergency use (an “EUA declaration”), to authorize the emergency use of an unapproved product or an unapproved use of an approved product for certain emergency circumstances. The list of all authorized COVID-19 device EUAs is available online here.
An EUA issued under section 564 of the FDCA only remains in effect for the duration of the relevant EUA declaration, or until FDA chooses to revoke the EUA because the criteria for issuance are no longer met or revocation is appropriate to protect public health or safety. However, as FDA notes in in the EUA draft guidance, “given the magnitude of the COVID-19 PHE,” and continued challenges associated with the manufacture, distribution, and use of devices in the context of the COVID-19 PHE, FDA stated that it “recognizes that continued flexibility” will be appropriate as companies return to normal business operations.
180-day notice of EUA termination
The EUA draft guidance contemplates that the advance notice of termination of each EUA declaration pertaining to devices will be published in the Federal Register 180 days before the day on which the EUA declaration is terminated. For the time between the advance notice of termination of an EUA declaration and the EUA termination date, manufacturers of devices with EUAs authorized pursuant to such an EUA declaration and others must continue to comply with the terms of the devices’ respective EUAs, including applicable Conditions of Authorization identified in the EUA letters of authorization for the devices. Notably, some of these conditions of authorization may also apply to parties other than the manufacturer, such as health care facilities or distributors.
At the time of the EUA termination date, FDA expects discontinuation of distribution of that the EUA-authorized device if the manufacturer has not submitted a required marketing submission that has been accepted for review even if the review is still ongoing. Commercial distribution of such devices may continue in this time frame, but must cease in the event that the manufacturer receives a negative decision on its marketing submission as FDA’s final action, or the manufacturer withdraws its submission or fails to provide a complete response to an FDA request for additional information within the time identified in FDA’s letter.
FDA urges in the draft guidance for manufacturers of devices authorized under EUAs to plan now, even while the pandemic is ongoing, their post-EUA regulatory and disposition strategies.
FDA requests “notification of intent” to discontinue life-supporting/sustaining EUA devices
For manufacturers of reusable life-supporting or life-sustaining devices that have been issued an EUA, FDA requests that manufacturers submit to FDA information regarding whether or not they intend to submit a marketing submission to continue distributing their product after the EUA termination date. Table 1 of the draft guidance lists 11 product codes that will require the notifications, including ventilators, oxygen delivery devices, and anesthesia machines.
FDA directs EUA holders to send any notifications of intent to discontinue distribution of these devices "as soon as possible" after the guidance is finalized.
FDA requests “transition implementation plan”
Marketing submissions for emergency use authorized devices that intend to continue distributing their devices after the EUA termination date should include a “transition implementation plan” that addresses the manufacturers’ plans for dealing both with devices already distributed in the case of a positive decision, and handling of devices in the case of a negative decision on the marketing submission. The guidance includes the expected content of transition implementation plans.
FDA writes that this plan should include the following information, as applicable:
- Estimated number of devices under an EUA currently that are in U.S. distribution.
- In the event of a negative decision on the marketing submission, an explanation of the manufacturer’s benefit-risk based plan for disposition of already distributed product.
- If the manufacturer is proposing to leave already distributed product in place, the plan should address the rationale for doing so and considerations, such as:
- the process for providing users, patients, facilities, and distributors of the device’s regulatory status; and
- the process and timeline for restoring distributed devices to the previously FDA cleared/approved version and providing updated labeling accurately describing the product features and regulatory status.
- A description of the maintenance plan for distributed devices.
- An explanation of the manufacturer’s plans for addressing already-distributed product in the event of a positive decision on the marketing submission, including considerations such as updating labeling and the timeline for distribution of such labeling to existing users.
Exceptions to market removal rule
The draft guidance explains what a manufacturer should do if they do not intend to continue to distribute their device after the EUA termination date. Generally, FDA requires manufacturers to dispose of already distributed medical devices when an EUA is terminated. However, for COVID-19 related EUA terminations, if a manufacturer does not intend to continue distribution of its device after the EUA termination date, FDA says it will make an exception to that general rule and not request market removal for devices distributed before the EUA termination date in the following circumstances:
For any single use, non-life-supporting/non-life-sustaining devices (e.g., face masks) that were consumed by the end user.
For reusable, non-life-supporting/non-life-sustaining devices (e.g., remote patient monitoring devices) the device must be either:
Be restored by the manufacturer to the previously FDA-cleared/approved version (e.g., earlier software version, component replacement), or
Have publicly available labeling that accurately describes the product features and regulatory status (i.e., that the product lacks FDA clearance or approval).
For reusable life-supporting/life-sustaining devices (e.g., ventilators, extracorporeal membrane oxygenation systems, continuous renal replacement therapy systems) the device must be either:
Be restored by the manufacturer to the previously FDA-cleared/approved version of the device, or
Have both publicly available and a physical copy of labeling that accurately describes the product features and regulatory status.
For in vitro diagnostic devices that are used for no more than 2 years after the EUA termination date or until their expiration date, whichever is less.
The draft guidance notes that companies awaiting a marketing decision by the FDA must continue to comply with the agency's regulatory requirements for quality systems, Medical Device Reporting, recalls and Unique Device Identification, as applicable per the conditions of the EUA.
II. Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
FDA said in a second draft guidance, which applies to devices that fall within temporary COVID-19 enforcement policies, that medical device manufacturers will have 180 days following the expiration of the public health emergency to bring their products into compliance with the FDA’s normal regulations. The draft guidance lays out a three-phased transition plan for devices that fall within the guidance’s scope:
Phase 1: Beginning on the guidance’s “implementation date,” if not already doing so, manufacturers should follow adverse event reporting requirements (found in 21 CFR Part 803) in order to prepare for Phase 3.
Phase 2: This phase starts 90 days after the implementation date. Before the start of Phase 2, if not already doing so, manufacturers should follow the corrections and removals requirements (21 CFR Part 806), and if planning to continue to distribute their devices after the transition period, should also ensure compliance with registration and listing requirements (21 CFR Part 807 Subparts B-D).
Phase 3: FDA will withdraw its COVID-19 related enforcement policies (17 of which are enumerated in “List 1” of the draft guidance) 180 days after the “implementation date” and medical device manufacturers will then be expected to comply with all statutory and regulatory requirements applicable to their devices (e.g., 21 CFR 218 Part 820, 21 CFR Part 801 Subpart B, and 21 CFR Part 830).
Prior to the start of Phase 3, FDA expects any marketing submission for a device within the scope of this guidance to be submitted and accepted if the manufacturer intends to continue distribution of the device, after the guidances in List 1 are withdrawn.
Where possible, FDA said it “strongly encourages” manufacturers to work to complete such submissions “well in advance” of the start of Phase 3 to avoid potential delays created by a large influx of new submissions.
As in the EUA draft guidance, FDA said it does not intend to object to continued distribution of devices within the scope of this guidance where a marketing submission has been submitted and accepted by FDA before the start of Phase 3 and FDA has not taken a final action on the marketing submission.
FDA again requests notifications of intent, transition implementation plan
As in the EUA draft guidance, FDA requests that manufacturers of reusable life-supporting or life-sustaining devices (complete list in Table 1 in the draft guidance), such as certain gas machines and ventilators, inform FDA regarding whether or not they intend to submit a marketing submission to continue distributing their product. The draft guidance adds that if a device was previously FDA-cleared/approved and a modified version was distributed as described in a policy in a guidance in List 1, the manufacturer should submit this information as a premarket notification (i.e., 510(k)) or PMA “amendment” to the manufacturer’s existing device submission that was previously cleared/approved.
As in the EUA draft guidance, FDA offers exceptions to the market removal rule, explaining what a manufacturer should do if they do not intend to continue to distribute their device after the EUA termination date. The agency iterates how it will make an exception to the general rule and not request market removal for devices distributed before the EUA termination date in the circumstances enumerated above in this client alert. The language in the transition plan draft guidance mirrors that in the EUA draft guidance, except that the transition plan guidance does not cover in vitro diagnostics (number 4 above).
FDA also repeats its recommendations from the EUA draft guidance that device manufacturers include a “transition implementation plan” along with any new marketing submission.
Both draft guidance documents also contain hypothetical examples intended to illustrate the transition policies outlined therein. For concerns not addressed by the new guidance, FDA recommends that manufacturers initiate discussions with the agency through the Q-Submission Program, including Pre-Submissions, to develop a plan to address their specific scenario.
In announcing these new guidance policies, Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH) said: "Since the start of the pandemic, the FDA has issued emergency use authorization for more than 800 devices that are essential to protecting the public health, including COVID-19 tests and PPE, and facilitated access to many more through its flexible policies. While we continue working to defeat this virus, the agency is seeking early feedback on a plan to assist stakeholders, including industry, health care professionals, and patients, with a smooth transition away from these temporary emergency measures to the eventual resumption of normal operations.”
On February 22, 2022, the FDA will host a webinar for industry and others interested in learning more about the draft guidances. FDA will also accept public comments on the guidance documents until March 23, 2022.
If you may wish to comment on the draft guidances, or have any questions on regulatory flexibility related to the COVID-19 public health emergency more generally, please contact any of the authors of this alert or the Hogan Lovells attorney with whom you generally work.
Authored by Randy Prebula, Lina Kontos, Blake Wilson, and Erkang Ai