Contact: Kelley Drye & Warren LLP (Washington, DC, USA)
On July 10, 2012, the Food and Drug Administration (“FDA”) published a proposed rule implementing Federal Food, Drug, and Cosmetic Act (“FD&C Act”) provisions establishing a unique device identification
system for medical devices. Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices: “Unique Device Identification System. The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.” The recently enacted Food and Drug Administration Safety and Innovation Act (“FDASIA”) reemphasized Congressional interest in developing a unique device identification system by directing FDA to issue a proposed rule for the system by December 31, 2012. The proposed rule would dovetail with § 605 of FDASIA which directs FDA to develop an improved device recall assessment program that would, at a minimum, identify:
1. Trends in the number and type of device recalls;
2. Which types of devices are most frequently subject to recall;
3. Underlying causes of device recalls.
The proposed unique identifier system is expected to capture the information necessary to allow FDA to fulfill this requirement.
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