FDA Delays Enforcement For Class III Reprocessed SUDs With Pending PMAs
This article was originally published in The Gray Sheet
Executive Summary
FDA's reuse policy does not follow precedents set by previous calls for PMAs from original equipment manufacturers, SterilMed argued in a partially successful petition to suspend enforcement actions on Class III device reprocessors.
You may also be interested in...
Single-Use Device Reprocessor 510(k) Requirements Delayed Until Summer
FDA announced at the eleventh hour that it will extend by six months the deadline for active enforcement of premarket requirements for reprocessors of Class II single-use devices, giving the firms a Valentine's Day reprieve
Single-Use Device Reprocessor 510(k) Requirements Delayed Until Summer
FDA announced at the eleventh hour that it will extend by six months the deadline for active enforcement of premarket requirements for reprocessors of Class II single-use devices, giving the firms a Valentine's Day reprieve
OEM Trademarks On Reprocessed Single-Use Devices Acceptable, FDA Says
FDA regulations do not require reprocessors to remove original equipment manufacturer (OEM) trademarks and references to OEMs from reprocessed devices, but the reprocessor must make clear that it, not the OEM, is the manufacturer of the reprocessed single-use device, FDA states in its Sept. 17 denial of a petition from the Association of Disposable Device Manufacturers.