If your company is among the recipients of more than 100 510(k) recission letters sent by CDRH, you are now arguably free to resume marketing the affected device.

October 1, 2014

4 Min Read
FDA 510(k) Rescission Letters are Illegal, Judges Rule

By Jim Dickinson

If your company is among the recipients of more than 100 letters from CDRH rescinding a marketing clearance under Sec. 510(k) of the Food Drug and Cosmetic Act, you’re now arguably free to resume marketing the affected device because FDA’s letters are illegal. That’s the bottom line of a September 26 decision by the Court of Appeals for the D.C. Circuit.

In a 2-1 decision with a whiff of politics about it, the George W. Bush–appointed majority overwhelmed its Obama-appointed colleague to rule in Ivy Sports Medicine v. Burwell that FDA cannot short-circuit the statutory medical device reclassification process by rescinding a 510(k) decision in what FDA artfully called an exercising of its “inherent reconsideration authority.”

In its 16-page decision, the court majority found that FDA did not exercise its clear statutory authority to reclassify Ivy Sports Medicine’s (successor company to bankrupted ReGen Biologics) Class II Collagen Scaffold surgical mesh 510(k) for knee meniscus repair. The decision reversed an earlier summary judgment awarded to FDA by the district court and ordered the agency to vacate its rescission decision and undergo further proceedings (reclassification).

“Reclassification would force the device off the market and require the device to undergo the extensive premarket approval process before it could again be marketed,” the appellate majority wrote. “That statutory reclassification process generally requires FDA to provide notice and an opportunity for comment before the agency reclassifies a device.”

Rather, FDA had asserted its so-called inherent reconsideration authority to rescind its clearance, forcing ReGen to immediately pull the scaffold from the market and file for bankruptcy in 2011.

In her dissenting opinion, judge Cornelia T.L. Pillard, appointed to the court by Presidet Obama in 2013, loyally took FDA’s side, challenging the majority’s insistence on the virtues of notice-and-comment ruling when correcting an “erroneous” agency decision.

“The court has it backwards in citing the accuracy benefits of notice and comment,” Pillard wrote. “Substantial equivalence decisions are prone to error in part because they are made without notice and comment ….
“I read the [a]ct to allow equivalence decisions to be reversed as readily as they are made (leaving open to a device manufacturer or importer to seek a more fully informed and thus accurate consideration of the device through the de novo process), which I believe better serves the [a]ct’s purpose of assuring the safety and effectiveness of medical devices than does the one-way ratchet that Ivy advocates.”

Pillard said the harms likely to flow from taking Ivy’s position “are likely to be multiplied, because devices cleared as substantially equivalent thereby qualify as predicate devices for future equivalence decisions.”

The surgical mesh was cleared in 2008 under former CDRH director Daniel Schultz’s leadership after years of review and separate input from an advisory panel of independent experts—and a lot of political involvement in FDA decision-making on ReGen’s behalf. (Schultz was appointed by a Republican, and though FDA center directors are not direct political appointees— indeed Schultz rose through the ranks as a career civil servant starting in 1994—elevations to center director level are always made by political appointees. In these cases the FDA commissioner made the elevations, but increasingly such appointments are vetted by the HHS secretary, a cabinet post. This unavoidably puts a political cast on many sensitive decisions, clearly seen in Collagen Scaffold case.)

Two years later—and following a change in top management at FDA under incoming Obamacrats—the agency took the unprecedented action of rereviewing the Collagen Scaffold’s clearance. Current Democrat-appointed CDRH head Jeffery Shuren justified the rereview by citing a September 2009 FDA Report, of which he was coauthor, titled “Review of the ReGen Menaflex: Departures from Process, Procedures, and Practices Leave the Basis for a Review Decision in Question.”

The report concluded that the original review of the device suffered from multiple internal FDA departures from processes, procedures, and practices—departures that were compounded by Congressional pressures.

Portraying the appellate majority’s decision as a victory of David over Goliath, a legal analysis by law firm Duval and Associates says it “provides a ray of hope that FDA cannot make-up-rules-as-they-go-along to achieve a result that a new FDA administration (Dr. Shuren’s), revisiting what a previous FDA [a]dministration (Dr. Schultz’s) had done just because the new administration has a differing scientific and regulatory opinion (and possibly another political agenda).”

The Minnesota-based firm notes that FDA has continually asked Congress to grant it rescission authority by statute. “If FDA truly does have inherent authority to rescind, it would not need to request legislation for express authority to rescind,” the firm writes. “To request that authority from Congress is to presume it is because FDA does not believe it has that authority. Importantly, Congress has refused to give FDA that authority, presumably out of concern it would be misused by the agency (certainly that is the argument and fear of industry).”

Jim Dickinson is MD+DI's contributing editor.


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