News and Updates

Upgrading Medical Device Safety Through End-To-End Traceability

FDA has announced some changes that have the potential to improve medical device safety. In PlasticsToday, its reported on proposed modifications to the 510(k) approval process, which allows new low- to medium-risk devices to be placed on the market if they can show substantial equivalence to an existing device. Currently, some of those predicate devices are decades-old. The agency is considering making public on its website cleared devices that have demonstrated substantial equivalence to devices that are more than 10 years old as the “starting point” of a broader overhaul of the regulatory process. FDA is also phasing in a system of unique device identification, notes Bastarache.