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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
Class IIb implantable devices, Class III devices, active implantable devices and certain in vitro diagnostics must be registered with the agency within four months of the UK’s exit. Read More
China’s State Council unveiled a plan to drive down high prices for medical devices and substitute expensive imports with locally made products. Read More