Legislation being introduced in the Senate would require the Department of Health and Human Services to issue a final rule establishing an unique medical device identifier by the end of 2012, and implement the identification system “as soon as practical.”
Sens. Tom Harkin (D-Iowa) and Michael Enzi (R-Wyo.), leaders of the Health, Education, Labor & Pensions Committee, introduced the Food and Drug Administration Safety and Innovation Act. It would amend current law to revise and extend user fee programs covering prescription drugs and medical devices, and establish user fee programs for generic drugs and certain biological products. Under the programs, the industry agrees to pay fees to help fund a portion of the FDA’s drug review activities while the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular timeframe.
The language mandating quick issuance of a device identifier was inserted in the legislation because a proposed rule from the Food and Drug Administration has been stalled since July 2011 while under review at the Office of Management and Budget. Under the rule, the unique identifier will identify a device through distribution and use, and may include the lot or serial number. A law requiring the identifier was enacted nearly five years ago. The Premier provider alliance applauds the Senate HELP committee for including the new device ID requirement in the FDA legislation.
The committee will hold an “executive session,” which is a type of hearing to go over provisions of the legislation, on April 25. The bill is available here.