Content tagged with safety

4 results

FDA lays out plans to improve post-market medical device oversight

The FDA today laid out plans for improving post-market medical device oversight, including a significant investment in its new National Evaluation System for health Technology.


FDA: Updated predicate devices will improve safety, efficacy in 510(k) clearances

The FDA yesterday released a notice explaining why it believes a push for modernizing predicate devices used in equivalence testing within the 510(k) clearance pathway will improve overall safety and effectiveness.


Israel expertise

Medical Device Manufacturers benefit from the partnership between genae and MedicSense as we now can provide pre- to post regulatory and quality expertise in addition to clinical trial management and digital health services.


FDA previews safety-focused STeP pathway, finalizes breakthrough device guidance

The FDA today outlined its plans for finalizing guidance on its Breakthrough Device Program as well as plans for a new Safer Technologies Program (STeP) intended to encourage device tech that significantly improves safety as compared to current devices on the market.