ARTICLE SUMMARY:
In this week’s roundup: FDA’s final COVID-19 transition guidance documents are imminent, CMS sets precedent with a virtual reality HCPCS reimbursement code, Europe enacts MDR extensions, and the UK looks to streamline regulatory routes, AdvaMed picks a new chair, and more global medtech policy updates.
Next Picks: Post-COVID Guides
What we’re watching for:
Look for FDA to publish final guidelines this week or early next week at the latest describing how it will transition out of COVID-19 emergency use authorizations (EUAs) and enforcement discretions for medical devices.
On March 17, the White House Office of Management and Budget completed review of the two guides, which were first issued as drafts in December 2021. FDA is expected to update various elements in the final guides, but retain the basic transitional frameworks introduced in the drafts. The EUA guidance (draft here) features FDA plans to provide 180-day advanced notice before HHS terminates currently active declarations (564 declarations) allowing EUAs, to give developers time to submit a traditional premarket submission (e.g., 510(k) or De Novo) or pull an EUA product from the market. The enforcement discretion guidance (draft here) includes a similar planned 180-day transition for guidance documents that have granted COVID-19-era marketing flexibility for various device types, linked to the end of the federal Public Health Emergency (PHE). The Biden administration has announced it will let the COVID-19 PHE expire on May 11, when the wind-down clock will start for 15 CDRH enforcement discretion guidance documents. The center has identified four other COVID-19 flex guidances that will be updated and then retained for the long term.
During a March 22 call, CDRH diagnostics officials affirmed the transition guidances were imminent, and that the EUA 564 declarations were completely independent of the PHE expiration, and there was no sense of timing yet on ending the former. Wednesdays call was the 102nd recurring “virtual town hall” that IVD staff have held since 2020 to answer questions about development of COVID-19 (and, more recently, Mpox) diagnostics. And, in another sign of the COVID-era transition, FDA announced it would be the final session. “From my heart to yours, thank you for all the work developers have done,” said IVD office director Tim Stenzel, in signing off the call.
