FDA to exert new controls over medical device industry


The final rule creates a national “unique device identification” (UDI) system enabling the FDA to more easily track products, and recall them when problems arise, according to the agency.

“UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Under the new system, all medical device makes and models will be give unique numbers allowing government and consumers to pinpoint the product’s lot and what batch it came from, along with manufacturing and expiration dates.

The FDA will set up a publicly searchable database that will catalogue every applicable device, and corresponding information. The FDA emphasized that the database will include no personal patient information.

The agency plans to phase in mandatory participation in the new system, with products deemed to present the highest risks incorporated first. Those devices will be required to carry identifying numbers within a year, with manufacturers responsible for submitting corresponding information to the database.

Companies will have three years to bring devices deemed to carry moderate risks into the system and many lower risk products must be included within five years.

Some low risk devices will be exempt from the system, according to the FDA.

A leading industry group offered tempered support for the regulation.

"While we continue to review this final rule, it appears that FDA addressed a number of issues raised by stakeholders, said Mark Leahey, president and CEO of the Medical Device Manufacturers Association. “At the end of the day, both innovators and patients are best served by a cost effective and efficient UDI system.”