July 29, 2013 Articles

The Case for Leaving the 510(k) Argument Out of a Pleading

By Prof. Jim O'Reilly

A well-written article in this issue brings a younger, fresher perspective to the defense of medical-device makers, and I encourage you to carefully consider those viewpoints. With due respect, I represent a very vanishing breed, the creators of the 1976 Medical Device Amendments, so it may be useful to have some history of the 510(k) "on the record" before this dinosaur fades from the scene.

"Medical devices" as a regulatory category had been ignored, sitting quietly in the corner of a very active regulatory field as bad drugs and foods were challenged from 1906 into the 1970s, and remained in obscurity as the Supreme Court struggled with diagnostic products in United States v. Bacto-Unidisk, 394 U.S. 784 (1969), a decision that had to stretch far to call diagnostics "drugs" for lack of any other vehicle for their regulation. By the mid-1970s, General Electric's painful experiences with bad electrical lead wires for heart pumps drew public attention to physical and mechanical objects that would not fit the "drug" world. Who would step in? The then-new (1972) consumer product safety legislation had excluded these human-use medical items, and there was reluctance in the post-Nixon era to create another federal agency. The Centers for Disease Control and Prevention, the National Institutes of Health, and the states all had some roles in the process, on issues as small as Massachusetts hearing aid rules, which gave impetus to the preemption provision of the 1976 law.

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