FDA issues draft guidance for transitioning medical devices
06 January 2022
The FDA is proposing guidance that it give medical device makers about half a year’s notice before terminating emergency use authorizations post-pandemic.
That was one of the major takeaways from the draft guidance that the FDA released today. It considers ways to transition medical device regulation once COVID-19 moves from a pandemic to an endemic phase. There are presently hundreds of medical devices sold in the U.S. under EUAs issued during the pandemic.
The FDA said its draft guidance aims to help prepare manufacturers and other stakeholders for the orderly and transparent transition to the eventual resumption of normal operations in a post-pandemic world.
AdvaMed CEO Scott Whitaker in a statement shared with MassDevice echoed the desire for a smooth transition.
“From the outset of the COVID-19 pandemic, medtech companies stepped up in a big way, ensuring patients and health care providers had the equipment they needed,” Whitaker said. “We worked with our members and the Administration to ensure safe and effective medical devices were quickly authorized, especially when time made all the difference for countless patients. Now, as we plan for the future and post-EUA regulations, we will continue to work with FDA to ensure a smooth transition for medtech companies whose products fall under this classification.”
In a separate statement, the FDA said it anticipates a gradual transition back toward normal review timelines in 2022, depending on the pandemic’s course and access to adequate resources.
The guidance floats the notion of the advance notice of termination of each emergency use authorization declaration being published in the federal register 180 days before the day on which the FDA EUA declaration is officially terminated. During the 180-day period, manufacturers of devices with EUAs must continue to comply with the terms of the EUAs.
According to the guidance, the FDA recommends that manufacturers of such devices authorized under EUAs plan now — as the pandemic continues — their post-EUA regulatory and disposition strategies.
Manufacturers of authorized devices who intend to continue distributing after the EUA termination date are urged by the FDA to submit their marketing submissions with sufficient time to be accepted by the FDA before the termination date. The FDA expects some changes or updates to the device during that submission period. The regulatory body may engage with the manufacturer during its review to discuss the appropriate disposition of already-distributed devices.
After the EUA termination date and while an accepted marketing submission is under consideration by the FDA and after receiving marketing authorization, the agency expects manufacturers to comply with all applicable regulatory requirements for the device/manufacturer.
The FDA shared the draft guidance for stakeholders to comment on whether the 180-day period proposed for advance notice of EUA termination would sufficiently allow for an appropriate transition period that avoids exacerbating product shortages and supply chain disruptions.
Additionally, the FDA aims to find out from stakeholders if its guidance with a proposed transition policy requesting public comment may help to satisfy or determine how to satisfy (while also effectively managing resources) the requirement to consult with a manufacturer that was issued a EUA for an unapproved product on the appropriate disposition of that product.
“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,” Director of the FDA’s Center for Devices & Radiological Health Dr. Jeff Shuren said in a release. “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.”
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Also published on Massdevice.com