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The FDA said it “continues to receive a high volume of pre-submissions from industry requesting feedback about the necessary data to support pivotal clinical studies and marketing applications for a wide variety of device designs intended for weight loss.” Read More
The best way to improve innovation and safety in the 510(k) program “is to drive innovators toward reliance on more modern predicate devices or objective performance criteria,” said CDRH Director Jeffrey Shuren. Read More
China’s National Medical Products Administration is gearing up to implement a unique device identification system and it has created a pilot program that will focus on high-risk implantable devices first. Read More
The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis. Read More
The FDA is making new recommendations to manufacturers of duodenoscopes to transition to new designs that will eliminate the need for reprocessing. Read More
The International Medical Device Regulators Forum (IMDRF) has issued a new draft document on harmonizing terminology and codes for reporting adverse events for medical devices and in vitro diagnostics. Read More
As part of its ongoing overhaul of the 510(k) process, CDRH released finalized guidances on its special 510(k) and abbreviated 510(k) programs, on its refuse-to-accept policy for 510(k)s and on formatting recommendations for submissions. Read More
The FDA finalized three guidance documents related to de novo classification requests for clearance when there is no predicate device for comparison. Read More
“The continuous, robust generation of evidence throughout the premarket and postmarket setting … is important to continuously refine our understanding of how medical devices are used and perform,” the agency said. Read More