In the May 1 Federal Register, FDA issued a proposal to
reclassify surgical mesh for transvaginal pelvic organ prolapse
repair from class II to class III, based on the tentative
determination that general controls and special controls together
are not sufficient to provide reasonable assurance of safety and
effectiveness. In a separate notice, the Agency outlined when premarket
approval would be required: within 90 days of the effective date of
a final order on the proposal or on the last day of the 30th
calendar month after the reclassification becomes effective,
whichever occurs later. In addition, FDA proposes to reclassify
urogynecologic surgical mesh instrumentation from class I to class
II with special controls. Comments on these proposals
are due July 30.
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Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k "substantially equivalence" medical device clearance as non-preemptive because it was supposedly "focused on equivalence, not safety"? Id. at 493.
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