Originally published February 1996
Vigorously opposed to FDA commissioner Kessler's tobacco initiative, MDMA is urging the agency at least to go through the device classification process set out in the 1976 Medical Device Amendments before it declares tobacco products to be nicotine-delivering medical devices. MDMA counsel Larry Pilot of the law firm McKenna & Cuneo (Washington, DC) wrote in a comment to the tobacco proposal docket (95 N-0253) that if FDA believes tobacco products are medical devices, "it must first propose to identify specifically what is a device and apply the requirements of the [Federal Food, Drug, and Cosmetic] Act applicable to classification of devices." Unless this is done, Pilot avers, FDA's approach is "fundamentally flawed" because it is not based on congressional authorization.
Pilot mocked FDA's "distorted interpretation" of the term device as used in the tobacco proposal, saying that if such a definition were upheld in litigation, then any "thing" that affected the structure or function of the body could become subject to regulation as a device--including furniture, eating utensils, transportation products, clothing, and heating and cooling systems.
Firm-initiated recalls that involve device modifications to correct the cause of the recall will have speedier reviews under a new guidance designed to eliminate redundant procedures. CDRH's "Guidance on Recall and Premarket Notification Review Procedures during Firm-Initiated Recalls of Legally Marketed Devices" will triage the modifications to determine whether they should be reviewed under the recall process or under premarket notification--as opposed to both, as was the case under the previous guidance.
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.