Shawn M. Schmitt
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Shawn M. Schmitt
A patient's point of view is paramount as the Center for Devices and Radiological Health embarks on a plan to conduct patient-perspective studies to ascertain what device-users want and value when it comes to health care. But don't call it a "survey" – "this is real research," CDRH compliance chief Robin Newman says.
A count of fiscal year 2016 recalls provided by the agency shows that there were 43 high-risk class I (4%), 1,090 class II (92%) and 50 class III (4%) recalls last year, up a mere percentage point from the prior year. Device-makers had been on pace for a more modest number of corrections and removals for 2016, but a sudden mid-calendar-year spike in recalls caused the total to jump significantly.
US FDA Device Center Pushes 'Total Product Life Cycle' Concept; 'Reorganization' Coming, Says Compliance Chief
The Center for Devices and Radiological Health is shaking up how its pre- and post-market specialists interact under a new "Total Product Life Cycle" scheme.
In this Medtech Insight podcast, Xavier University's Marla Philips explains why the school is teaming up with IBM Watson Health to launch a Center for Artificial Intelligence. "Our mission is to provide artificial intelligence solutions. We will have free and open access for anyone to use so they can implement those solutions across the pharma and device industries, and FDA itself," she says. Also: will AI steal human jobs?
The agency's new inspectional approach – which will be structured along commodity-specific product lines – will be ready for primetime on May 15, the device center's compliance chief says.
Warning Letter Nosedive: US FDA Writes Fewest Quality-Related Missives Since 2002; Agency Isn't Sure Why
Only 57 quality-related warning letters were issued to device manufacturers in 2016, a 14-year-low that has left US FDA scratching its head as to why so few were sent to firms. "Our analyst team talked to both managers and staff alike within the device center, within ORA, and we could not identify a single factor or event to attribute the drop to," FDA compliance office official Sean Boyd said in an interview. Also: US inspections are down 2%, while foreign audits are up 16%; the top three quality system violations are revealed by FDA; an update on the number of close-out letters sent to firms; and more.