The FDA’s highly anticipated predetermined chance control plan (PCCP) guidance document is pretty much what the industry expected, Sidley Austin partner Deeona Gaskin told Medtech Insight.
Since 2019, manufacturers of medical devices with artificial intelligence and machine learning capabilities have been awaiting official guidance on submitting post-market changes to the US Food and Drug Administration.
When the Food and Drug Omnibus Reform Act of 2022 Act passed at the end of December, which gave the...
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.
So far, calls for much needed changes to the medtech regulatory system have focused on the Medical Device Regulation. Don’t neglect the IVD Regulation, industry says.
This week, two device testing labs in China landed FDA warning letters; refunds for 1Health.io clients; FDA AR/VR product list expands.
This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.
