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Hutt, P. Barton, Merrill, Richard A. and Grossman, L. A., Food and Drug Law: Cases and Materials, 3rd ed. (Foundation Press, New York, 2007)[hereafter Hutt]. The chapter on Medical Devices (Chapter VII) in this definitive casebook makes this point definitively on p.997: “Safety and Effectiveness Data. The 1990 Act specifically authorized FDA to require (emphasis added) clinical data in a section 510(k) notification. Many PMN's include such data. Indeed, FDA would be unlikely to clear a PMN for a product incorporating new technologies that could affect safety or effectiveness if the notification did not contain clinical investigation data. Nevertheless, FDA assiduously avoids mentioning safety or effectiveness is letters clearing PMNs, and the agency clings to its position that a 510(k) clearance reflects a determination of equivalence, not safety and effectiveness. This distinction was critical in the Supreme Court's conclusions that a PMN clearance does not preempt a state tort action based on a devices allegedly defective design. Medtronic, Inc. v. Lohr 518 U.S. 470 492–94 (1996).” The fact is, though, that requiring submission of more, and new, data is not just equivalence; if the devices were truly equivalent there would be no need to require more safety and efficacy data, particularly on the rare occasion where new clinical trial data may be required for a 510(k).Google Scholar

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Id. The fact that 1200 hours is required to complete a PMA is irrelevant, regardless of how impressive this appears to the court. CDRH's review for substantial equivalence is known as the §510k process, named after the section of the MDA which describes the process. The point is that it is still a review, there is a process for the review, and requirements which must be met by the manufacturer for the review to be completed successfully. No question, it does not contain the full reports, studies, investigations of the device's safety and efficacy nor a “full statement” of the devices components which is required for the PMA, but it does have requirements. The requirements are not so specific as those for a PMA (and in that sense are “more general”).Google Scholar

Id. The ruse the court uses to allow Lohr to stand is to allow products entering the market via 510k approval to do as an exception to the preemption statute of MDA, not under the “requirement” penumbra. Yet, a 510k review is not a simple rubber stamp of identical data for the relevant pre-1976 device it is substantially equivalent to, although the court seems to suggest this is the case. As noted, there is data, there is a review with requirements for safety and efficacy data submitted, and occasionally they are not approved because the requirements were not met. The 510k is an exception to the need to submit a PMA, not an exception to the fact that safety and efficacy data is required.Google Scholar

CDRH greatly prefers the 510k route for class III device approval. It is easier, shorter, and consumes significantly less review time and scarce agency resources for an agency generally acknowledged to be woefully understaffed and under-funded.Google Scholar

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Id. See also Hutt, , supra note 25, Chapter VII on Medical Devices: “In 2005, for example, the FDA authorized the marketing of 3,148 devices under 510(k) and granted premarket approval to just 32 devices.”Google Scholar

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Id. Interestingly, there is surprising little data to support the contention that federal regulation of devices (or drugs or biologics, for that matter) “stifles” innovation. As a rule companies never announce that they are not going to develop products simply because there are regulatory requirements they must comply with for approval. Politically though it can be a winner ever if impossible to fairly test. If a state (e.g., California) were to have additional, more stringent class III medical device FDA-approved by a PMA, this would not interfere with the FDA approval process perse but would interfere with national marketing of the product.Google Scholar

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