In this week’s roundup: FDA unveils its long-anticipated draft guide duo outlining expectations for transitioning emergency products to standard approvals, and issues other guidance documents. EU lawmakers approve the plan to extend and expand the IVDR grace period, and expert panels drop more reviews. Medicare finalizes a plan to pay for adjunctive continuous glucose monitors, and much more.
Look for the next edition of Pathways’ Picks on January 5, 2022.
FDA went on overdrive in issuing new guidance documents this week, including its long-awaited guides on transition plans for devices marketed under emergency authorizations and COVID flexibilities. EU policymakers approved a bottleneck-relief plan for the IVD Regulation. Those and many more medtech policy updates as 2021 races to a close.
FDA Unveils COVID Transition Plan
Long-anticipated guides released:
The device center is trying to move toward turning a corner on COVID-19 in 2022 with the release of two long-awaited draft guidance documents intended to map out a post-emergency transition plan for devices marketed under flexible pandemic requirements. FDA has been working on the guides addressing emergency use authorizations and enforcement discretions, respectively, for more than a year.
Including individually granted EUAs and “umbrella” EUAs, well over 1,000 products, including tests, personal protective equipment, and other devices have been granted emergency use authorizations. At some point, FDA is going to need to terminate the EUAs, likely sometime after the official public health emergency (PHE) is declared over. The EUA draft guidance states FDA will issue public termination notices for EUA categories 180 days before the terminations will take effect. Manufacturers that want to keep a product on the market after that period are expected to take steps toward compliance, including quality systems activities, and to submit a traditional market application (510(k), PMA, or de novo) before the end date. Companies would be able to continue to sell a product after the termination date while a submission is under review. FDA “recommends” manufacturers of certain reusable devices that are life-sustaining or -supporting to send a letter of intent to the agency if they plan to submit a marketing application so FDA can plan for the proper resources. Companies will also need to have a plan in place to address distributed devices if FDA rejects the full application or if there are differences between the conventionally cleared device and the EUA version.
Hundreds of other devices have benefited from flexibilities detailed in 17 COVID-19 enforcement discretion guidances issued by FDA over the past two years. Companies have rolled out unapproved devices or indications, generally to support remote care and management, based on the allowances in these guides. The enforcement discretion transition draft guidance takes a similar approach to the EUA guide. The key takeaway: assuming the guidance is finalized before the PHE ends, firms will have 180 days from the end of the PHE to bring devices into compliance and submit marketing applications.
In both draft guides, FDA offers leeway, for instance, for companies that are not traditional device manufacturers and may need more time to comply with the Quality System Regulation.
The transition draft guidances come as FDA is trying take steps to slowly return to closer to normal functioning, even as its diagnostics office, in particular, struggles to respond to the evolving virus needs. On December 21, CDRH officials said they hoped to be able to transition back to meeting most MDUFA reform performance goals in 2022, and that the diagnostics office would be able to start accepting presubmissions for more types of non-COVID IVDs.