Single-use device reuse
This article was originally published in The Gray Sheet
FDA denies Medical Device Manufacturers Association citizen petition proposing FDA ban reprocessing of single-use devices. Last June, MDMA requested a 180-day stay of action on the petition, originally filed in May 1999
You may also be interested in...
FDA should articulate a policy on reprocessing Class I 510(k)-exempt single-use devices rather than taking action only when problems with a particular product are brought to the agency's attention, according to the Medical Device Manufacturers Association.
FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.