Pathways’ Picks September 21: e510(k)s, Brazil Reforms, EU Updates, and More

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In this week’s roundup: Looking for a user fee deal, breakthrough devices for health disparities, FDA sets date for mandating fully electronic 510(k)s, FBI and FDA cyber warnings, Brazil finalizes device reforms, digital health updates and more from Europe, and dates to remember.

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What we’re watching for:

Breakthrough devices and health disparities. Look out for a draft guidance in the coming weeks updating elements of FDA’s Breakthrough Devices Program with an eye toward “reducing disparities in health and healthcare.” The agency has completed work on the draft and, as of September 15, it is under review by the White House Office of Management and Budget. FDA hasn’t signaled what types of updates will be included in the draft, but we are looking to see if the agency adds language focused on addressing disparities in describing the statutory criteria for Breakthrough Designation. 

User fee deal? There are less than 10 days before FDA’s user fee programs expire, but no word yet from Congress on a reauthorization agreement (even as reports of back-room negotiations continue). Despite the unprecedented delay, agency watchers—and FDA itself—continue to believe Congress will come through with an 11th-hour deal. Not only do user fees expire on September 30, but so do congressional appropriations to FDA and other federal agencies. It’s likely that user fee reauthorization will be attached to a short-term continuing resolution to fund the government, but that is not assured. In the meantime, as we reported last week, FDA’s device center says it has contingency plans in place to move forward with just about all MDUFA V commitments even if Congress does not approve new user fee collections by next Friday.


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