ARTICLE SUMMARY:
Device cybersecurity, predetermined change plans, and remote FDA inspections are in; a diagnostics overhaul and stricter device shortage reporting requirements are out. 10 takeaways for medtech from the $1.7 trillion US federal spending package heading for passage in Congress this week.
Comprehensive diagnostic regulatory reform didn’t make it into an end-of-year $1.7 trillion US federal funding bill, but about a dozen other FDA provisions, including new device cybersecurity authorities, as well as some Medicare fixes and telehealth measures, are set to pass this week as part of the package.
Funding for the government is scheduled to run out December 23 following several short-term extensions of fiscal year 2022 (ended September 30) budgets. But Congress finally reached agreement this week on a so-called omnibus package to fund the entire federal government at new levels through next September. That means more money for FDA and other agencies, and it also means policy updates across the government that have been added to the legislation.
Other than the VALID Act diagnostics reforms (see the first point below), just about all of the medtech-related riders that were dropped from FDA user fee legislation earlier this year are included in the year-end package. (See “House vs. Senate vs. Senate: FDA Bills Diverge,” Market Pathways, July 18, 2022.) There is also an entire section of pandemic preparedness reforms. Here are 10 takeaways from the bill for medtech.
(Note: Congress and the president have until Friday at midnight to enact the measure, so it’s still possible for the deal to falter. But at the moment, lawmakers are expected to pass it.)
