![]() ![]() The court called the process “grandfathering” and said it simply required equivalence to a device sold in before 1976 that the FDA had never specifically reviewed for safety. The Court emphasized the lax nature of the transitional clearance process Congress had created to handle the temporary problem of artificial monopolies. The Lohr opinion held that this form of regulatory review did not impose any “requirement” that would preempt state tort “requirements.” 518 U.S. This procedure was temporary, intended by Congress to prevent the onset of device regulation from creating artificial monopolies. All the manufacturer had to do to be able to market such a device was to file a “510(k) notice.” The FDA reviewed the notices but did not then have to grant permission before the device could be sold. Despite that classification, the statute allowed it to be cleared even before approval based on its equivalence to a device on the market in 1976, when MDA device regulation began. The device in Lohr was in the most risky class, Class III, which meant that the FDA had determined that it might present an unreasonable risk of illness or injury. The device at issue in Lohr was cleared in 1982 pursuant to the transitional provisions in the statute that lasted only until devices were initially classified in Classes I or II, or met the standards for premarket approval in Class III. Clearance of the device is an individualized safety determination, just as a judge’s decision in a case based on case precedents is an individualized legal determination. § 807.81 (a)(3), and has before it not only the contents of the 510(k), but also the regulatory history of the predicate device or devices and the record for other devices of the same type. When the FDA now makes a judgment as to equivalence to a predicate device, it examines what “significant changes” the manufacturer may have made, 21 C.F.R. Once the FDA initially established device types, 510(k) clearance of a Class II device requires equivalence in safety and effectiveness to a predicate Class II device. That is a safety determination that applies to the entire type. Of particular importance to modern device litigation is that the FDA’s placement of a device type in Class II meant that the agency determined, as a matter of law, that the device did not “present a potential unreasonable risk of illness or injury” that would require it to be in Class III. This process took place, and was completed, in the 15 years after the Medical Device Amendments (“MDA”) were enacted in 1976. After opportunity for notice and comment, the FDA promulgated literally hundreds of regulations classifying device types. The panels published their findings, with supporting citations, in the Federal Register. Congress dictated the composition of medical panels that FDA used for the initial classification of device types into Classes I, II and III according to the risk they presented. The device classification process is something Congress took seriously. From the very beginning, Congress created a process of device classification that drew a legal distinction between the temporary process at issue in Lohr and the permanent 510(k) process that came after it. The truth is that Congress never intended for the process described in Lohr to last, and it did not. The reasons for Lohr’s irrelevance go deeper than the reason most commonly given, i.e., that the 1990 amendments to the Medical Device Act strengthened the 510(k) process and, for the first time, required the FDA to clear devices before they could be marketed. ![]() 6 (2021), provides the details, and it is hardly alone in its conclusions. FDA: A Lesson from Pelvic Mesh Litigation on Relative Competence to Decide a Legal Question,” 76 Food & Drug L.J. This author’s article in the Food and Drug Law Journal, L. The 1982 world it describes disappeared decades ago. 470 (1996), has nothing useful to say about the FDA’s current system for clearing medical devices. As always, our guest posters do their own work and thus deserve 100% of the credit (and any blame) for what they write.Īs previously stated, Medtronic, Inc. He is grateful to Jin Yoshikawa of that firm for his help with this post. This is a guest post by Luther Munford, Butler Snow LLP, who comes to us fresh from the pelvic mesh wars. ![]()
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