Reminder: Time’s Running Out To Comment On FDA’s Draft Quality Management System Regulation
The deadline is 24 May to comment on one of the biggest regulatory changes in the history of the US FDA’s device center.
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Jeff Shuren, director of the US FDA’s device center, said on 4 May that the agency “thought it was enough time” when it proposed a one-year transition time frame from its current Quality System Regulation to the new Quality Management System Regulation.
The tens of thousands of Medical Device Reports sent to the US agency included 124 reports of death associated with Philips’ June 2021 recall of millions of BiPAPs, CPAPs, and other mechanical ventilator devices.
Under the US FDA’s voluntary 510(k) Sterility Change Master File Pilot Program, nine firms will be selected to send to the agency updated master files that detail novel sterilization processes without the need to submit a new 510(k). The goal is to move industry away from using ethylene oxide (EtO) to sterilize devices.