The US FDA says in a pair of final guidance documents that makers of the resins and screw systems don’t have to compare their devices to already-marketed products when submitting a 510(k) to the agency for review.
The US Food and Drug Administration says in a pair of final guidance documents that makers of denture base resins and facet screw systems don’t have to compare their products to already-marketed medical devices when submitting a 510(k) to the agency for review.
“Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway” and “Facet Screw Systems – Performance...
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.
