In this week’s roundup: a big digital health week at FDA; Congress addresses user fees; EU notified body news; updates from India, Singapore, and China; US and Canada take steps back on emergency COVID-19 test policies; FDA guidance and CMS coverage news; and dates to remember.
Digital health action at FDA and updates from Capitol Hill:
Big digital health week at FDA. FDA came out with two long-anticipated digital health documents this week—a final guidance on clinical decision support software, which has important near-term policy implications, and an autopsy report on the Software Precertification Pilot, which is focused more on FDA’s longer-term oversight goals. For more details, see “Big Digital Health Week at FDA: CDS Guide Final, PreCert Pilot Finished.”
Capitol Hill context. A simple user fee reauthorization, including the medical device MDUFA V agreement, is heading to passage in Congress this week as part of a package to avoid a government shutdown. Get more on where things stand this week and what’s next in Congress: “Capitol Hill Roundup: “Clean” User Fees, Eye on December, Cures 2.0 Lament.”