FDA Sued for Rescission of Menaflex’s 510(k) Clearance
A medical device manufacturer brought suit against the U.S. Food and Drug Administration (FDA) last week for rescinding the devices 510(k) clearance and reclassifying the device from a Class II device to a Class III device. The FDAs decision forced the manufacturer to undergo additional and more burdensome application processes, and significantly impacted the manufacturers ability to market the device in the United States. Class II devices are subject to 510(k) premarket notification review, whereby the FDA must determine whether a device is at least as safe and effective, that is, “substantially equivalent,” to a legally marketed device that is not subject to premarket approval, see 21 CFR 807. Class III devices, on the other hand, are subject to premarket approval (PMA), which is based on the determination that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s), see 21 CFR 814. PMA approval is the most stringent type of device marketing application required by the FDA and must be obtained before a Class III device can be marketed in the United States.
In 2008, the FDA classified the Menaflex, a collagen-based surgical mesh implant intended to reinforce damaged meniscal soft tissue, as a Class II device under the Food, Drug, and Cosmetic Act (FDCA). At that time the FDA found Menaflex to be substantially equivalent to surgical mesh, a legally marketed predicate device. On March 30, 2011, the FDA rescinded this 510(k) clearance and reclassified Menaflex as a Class III device. ReGen Biologics, the manufacturer of Menaflex (or the Collagen Meniscus Implant, the name under which the device is distributed outside of the United States), filed for bankruptcy one month later.
Last month, ReGen filed a petition with the U.S. Court of Appeals for the District of Columbia Circuit seeking review of the FDAs rescission of the Menaflexs 510(k) clearance. Pursuant to the Administrative Procedure Act, ReGen also filed suit in the U.S. District Court for the District of Columbia for declaratory and injunctive relief last week. In its complaint, ReGen claims that the FDCA does not grant the FDA authority to rescind a 510(k) clearance, and seeks an order setting aside the March 30, 2011 rescission letter “as arbitrary, capricious, an abuse of discretion and not in accordance with law, and in excess of statutory jurisdiction, authority and limitations.”
According to the complaint, the review of Menaflexs 510(k) clearance was allegedly prompted by a letter from three members of Congress who urged Dr. Joshua M. Sharfstein, the Principal Deputy Commissioner and Acting Commissioner of the FDA at that time, to look into Menaflexs substantial equivalence determination. The FDAs decision to grant 510(k) clearance was allegedly influenced by outside political pressures from lobbyists and politicians.
In September 2009, the FDA released a preliminary report, which revealed that “multiple departures from processes, procedures, and practices occurred.” Furthermore, the failure of important decision-makers to sufficiently explain and document the bases for their decisions in an administrative record constituted “a clear deviation from the principles of integrity used in this review” and also “undermine[d] the ability of the agency to counter the suggestion that lobbying on behalf of ReGen affected the decision.” The report also concluded that a “focused scientific reevaluation of the decision to clear the [Menaflex] device is warranted,” but it did not specifically provide evidence that the device was unsafe or ineffective. ReGen alleges that this report created a pretense to justify re-review of the devices Class II status.
ReGen claims that the FDA lacks explicit authority under FDCA to rescind 510(k) clearances. In 2001, the FDA issued a proposed rule that would authorize the FDA to reconsider and rescind a 510(k) clearance, but it did not finalize that rule. Although the FDA does have authority to reclassify a device from Class II to Class III, see Section 513(e) of the FDCA, or to withdraw premarket approval of devices, see Section 515(e) of the FDCA, the decision to rescind Menaflexs 510(k) clearance was not expressly authorized under either of those provisions. The FDA did not provide a statutory or regulatory basis for its decision and has not yet responded to ReGens complaint. It remains unclear whether the FDA has implicit authority under FDCA to rescind 510(k) clearances.
This decision raises interesting issues involving the FDAs regulation of medical devices, the Administrative Procedure Act, and legal principles of ripeness, exhaustion, and subject-matter jurisdiction. Fuerst Ittleman will continue to monitor the progress of these issues in this case. For more information, contact us at firstname.lastname@example.org.