Exclusive: FDA staff struggle to meet product review deadlines after DOGE layoffs
Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...
Fierce Biotech7h
FDA’s novel medical device clearances slow to a crawl
According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...
Medical Device Network on MSN10h
MedCAD secures FDA 510(k) clearance for AccuStride foot and ankle system
The AccuStride System is intended to enhance surgical outcomes for proximal phalanx and metatarsal arthroplasty.
Targeting FDA user fees would leave agency gutted, experts say
Critics worry that the user fee program creates a conflict of interest between the FDA and pharmaceutical companies.