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.