FDA proposes 180-day transition before terminating COVID-19 EUAs, enforcement policies

Regulatory NewsRegulatory News | 04 January 2022 |  By 

The US Food and Drug Administration (FDA) is proposing to give medical device makers 180-days’ notice before terminating emergency use authorizations (EUAs) and phasing out its enforcement policies for medical devices issued during the COVID-19 public health emergency (PHE).
 
The transition plan comes in the form of two draft guidances issued in late December, in which FDA explains that the transition policies are intended to “prepare manufacturers and other stakeholders for the transition to normal operations and foster compliance with applicable requirements under the [Federal Food, Drug, and Cosmetic Act] and implementing regulations when the relevant EUAs and COVID-19-related enforcement policies cease to be in effect.”
 
Precisely how the agency would transition products used on an emergency basis during the pandemic has been a matter of great concern for industry.
 
Both documents propose to give manufacturers and healthcare facilities 180 days’ notice to either discontinue distributing devices authorized under an EUA or covered by an enforcement policy or to seek permanent marketing authorization of their devices. Both documents lay out similar transition policies to ensure a smooth transition to normal operations and to avoid supply disruptions.
 
Guidance covers devices authorized under an EUA
 
Under FDA’s EUA transition guidance, the agency proposes to give device manufacturers 180 days’ advance notice of when the EUA declaration enabling the issuance of EUAs will be terminated.
 
The agency wants comment on whether the timetable allows for an “appropriate transition period that avoids exacerbating product shortages and supply chain disruptions,” according to an announcement.
 
FDA has issued EUAs for a vast array of medical devices during the pandemic including ventilators, infusion pumps, personal protective equipment, in vitro diagnostics and more.
 
For certain reusable life-supporting or life-sustaining devices, such as ventilators, portable oxygen generators and anesthesia gas machines, FDA calls for manufacturers to notify the agency of whether they intend to submit a marketing submission to continue distributing their product beyond the EUA termination date.
 
FDA requests that manufacturers of these devices submit the following information as soon as possible after the guidance is finalized: a “notification of intent” including contact information, the EUA request number, the submission number and whether the manufacturer plans to submit a marketing submission.
 
FDA also calls on manufacturers to submit their marketing submissions for any devices they intend to distribute after the EUA termination date “with sufficient time for the submission to be accepted by FDA before the EUA termination date.”
 
Manufacturers should also submit a “transition implementation” plan in their marketing submissions if they intend to distribute devices after the EUA termination date. The plan should address the estimated number of devices that are being distributed in the US under the EUA, and “benefit-risk based plans” for dealing with already distributed products in the event of a negative decision on the marketing submission.
 
FDA says that manufacturers whose marketing submissions are accepted may continue to distribute their device within the scope of the transition policy if the submission is accepted before the EUA termination date and prior to FDA’s final action on the submission. During that period, FDA says that labeling should be updated to reflect that the product was previously authorized under an EUA and is currently under review for clearance or approval.
 
The guidance also spells out FDA’s policy for products that will not be distributed after the EUA termination date. FDA says it “generally does not intend to object to the disposition of already distributed devices (i.e., FDA does not intend to request market removal).” Depending on the type of device, the manufacturer may need to restore the product to a previously cleared or approved version or update the labeling to reflect its regulatory status.
 
Otherwise, manufacturers will be expected to discontinue distribution of their devices on the EUA termination date, or upon the date the manufacturer receives a negative decision on its marketing submission, withdraws said submission or fails to provide a timely complete response to a request for additional information.
 
Transitioning devices approved though enforcement policies
 
FDA’s transition plan for devices that fall under enforcement policies similarly offers a 180-day transition period from an implementation date that will be determined based on the timing of the final guidance and the end of the PHE.
 
At the end of the 180-day transition period, FDA says it intends to withdraw the 17 enforcement policies it issued for various devices during the pandemic, including remote digital pathology devices, imaging systems, non-invasive fetal and maternal monitoring devices and digital devices for treating psychiatric disorders.
 
In the event FDA finalizes the guidance before the PHE declaration expires, the 180-day transition would begin the date the PHE declaration expires. If the guidance is finalized after the PHE declaration expires, FDA says it will announce an implementation date in the final guidance that is at least 45 days after the guidance is published.
 
The enforcement policy transition period is broken into three phases:
 
  • Phase 1 begins on the implementation date. FDA recommends manufacturers follow adverse event reporting requirements under 21 CFR Part 803.
  • Phase 2 begins 90 days after the implementation date. FDA says that manufacturers should begin complying with 21 CFR Part 806 regarding reports of corrections and removals requirements prior to the start of Phase 2. If the manufacture intends to continue distribution of their device after the transition period, they should also begin to follow 21 CFR Part 807 Subparts B-D for registration and listing requirements.
  • Phase 3 begins 180 days after the implementation date. FDA says it intends to withdraw the enforcement policy guidances listed in the transition plan and that manufacturers “will be expected to comply with all statutory and regulatory requirements applicable to their devices.”
 
Manufacturers that intend to continue distributing any devices that were covered under an enforcement policy should submit marketing submissions prior to the end of the transition period. “Where possible, FDA 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 and to best serve the public health,” the agency writes.
 
As with the EUA transition guidance, FDA says it does not intend to object to the continued distribution of devices for which marketing submissions have been submitted and accepted by FDA prior to the end of the transition period. Similarly, for certain reusable life-supporting or life-sustaining devices, FDA calls on manufacturers to submit a notification of intent prior to submitting a marketing submission. The guidance also recommends the inclusion of a transition implementation plan in their submissions.
 
FDA expects manufacturers to discontinue distributing the device if they have not submitted a marketing application before the beginning of Phase 3.
 
The guidance also offers some examples to show how the three-phase transition plan would work.
 
The deadline for submitting comments on both transition plan guidances is 23 March 2022.
 
FDA’s guidance on EUAs
 
FDA’s enforcement policy guidance

 

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