The FDA issued new timelines for its long-awaiting "unique device identifier" system for tracking and monitoring medical technology, cutting short some deadlines for implementation by as much as 5 years in order to comply with a new law.
The FDA Safety & Innovation Act, signed into law July 9, 2012, requires that all "implantable, life-saving (life-supporting), or life-sustaining" devices comply with UDI requirements within 2 years of publication of a final rule.
The federal watchdog agency had initially planned a phased launch of the UDI program, requiring Class III devices to comply fully within 1 year but staggering requirements for Class II and Class I devices of 3, 5 and 7 years.
The rule would require most medical devices to carry labels with unique codes and scannable barcodes that will allow healthcare providers, regulators and the public at large to track the devices and monitor safety.
While not required for patients’ medical records, the FDA also hopes the codes will be useful for physicians by allowing them to electronically capture information such as a device’s history and use, or even helping identify device shortages or counterfeit products.
The FDA Safety & Innovation Act also contained within the results of negotiations between FDA and medical device makers that doubled user fees for medtech review from $295 million over 5 years to $595 million, in exchange for the FDA meeting performance goals.
The new UDI proposal affect timeframes as follows:
|Class III implantable, life-supporting, and life-sustaining devices, and implantable, life-supporting, and life-sustaining devices licensed under the PHS Act.||No effect with respect to proposed requirement for device to bear UDI on the label and device package or proposed requirements for submission of data to the GUDID.|
|Class II implantable, life-supporting, and life-sustaining devices.||Implantable devices would have to bear a UDI as a permanent marking on the device itself 1 year earlier than first proposed.|
|Would have to bear a UDI on the label and device package and submit data to the GUDID 1 year earlier than first proposed.|
|Implantable devices would have to bear a UDI as a permanent marking on the device itself 3 years earlier than first proposed.|
|Class I implantable, life-supporting, and life-sustaining devices, and implantable, life-supporting, and life- sustaining devices that have not been classified into class I, II, or III.||Would have to bear a UDI on the label and device package and submit data to the GUDID 3 years earlier than first proposed.|
|Implantable devices would have to bear a UDI as a permanent marking on the device itself 5 years earlier than first proposed.|
The system has been a long time coming. Congress initially approved the UDI program in 2006 to enable tracking of medical implants and to add medical devices to the Sentinel post-market surveillance program that currently monitors prescription drug safety.
On June 4-5, DeviceTalks is taking over the Twin Cities medtech industry with one of the most anticipated conferences of the spring, bringing you the best and brightest minds in the industry.
Heidi Dohse: Sr. Program Manager, Healthcare, Google, Founder, Tour de Heart Foundation, Acessa Health Inc. Michael J. Pederson: Senior Vice President, Cardiac Arrhythmias and Heart Failure Division, Abbott Hon. Melvin Carter: Mayor, Saint Paul Tim Philips: Compliance Officer, FDA’s Office of Medical Device and Radiological Health Operations Dr. Myriam J. Curet, MD, FACS: Chief Medical Officer, Intuitive Surgical
Take a look at our incredible line up of speakers and join us now.
Use the code "KEYNOTE" to save 15% on the cost of registration.