FDA lays out medical device identifier system
WASHINGTON (AP) — Federal health regulators are proposing a new system to track millions of medical devices used in the U.S., an effort which they say will help protect patients by catching problematic implants earlier.
The Food and Drug Administration's proposal would require most medical devices to carry a unique code to identify the product's make, manufacturer and lot number. The codes would be stored in a publicly accessible database to help regulators, doctors and companies could monitor safety issues with devices.
The FDA will accept public comments on the proposal for about four months before finalizing it. Regulators plan to phase in the system gradually, starting with the highest risk devices. Devices sold over-the-counter at pharmacies and other retailers would not have to carry a code.