Device Week, 15 February 2022 – OMB’s Swift Review Of FDA’s Draft QSR

When the White House Office of Management and Budget, or OMB, sent the US FDA’s draft harmonized Quality System Regulation back to the agency after only 35 days of review, it raised some eyebrows in industry. Check out what experts are saying about the reg review time frame in this week’s podcast. Medtech Insight articles addressing topics discussed in this episode: • Too Slow, Too Fast, Or Just Right? Experts Weigh In On OMB’s 35-Day Review Of FDA’s Draft QSR • OMB Completes Review Of FDA’s Draft Harmonized Quality System Regulation • At Long Last, FDA Sends Draft Harmonized Quality System Regulation To OMB For Review