Shawn M. Schmitt
Latest From Shawn M. Schmitt
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.
The deadline is 24 May to comment on one of the biggest regulatory changes in the history of the US FDA’s device center.
Toxins that have been shown to cause adverse events in animals – including endocrine dysfunction and male reproductive effects – are emitted by tubing that’s part of Fresenius’ 2008T, 2008K2 and 2008K model devices, the US agency says in a letter to health care providers.
The draft document from the US agency looks to officially recognize a program aimed at advancing quality in medical devices and their manufacturing.
Digital Health: FDA’s Shuren Predicts ‘Critical Regulatory Hurdles’ If Congress Doesn’t Update Reg Frameworks
US FDA device center director Jeff Shuren is strongly urging lawmakers to come up with modern digital health regulatory frameworks and more strongly tackle cybersecurity issues.