Operon Strategist

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.

8 New Medical Devices Notified Under CDSCO

In a bid to regulate medical and diagnostic devices in India, the health ministry has notified eight medical equipment, in order to ensure better quality of medical devices imported into the country, the Union ministry of health and family welfare has added eight more devices to the list of drugs under the Drugs and Cosmetics Act, 1940, and will now require strict regulatory compliance.