Device Stakeholders Debate Whether FDA Can, Or Should, Revoke 510(k)s

Article reprinted from "The Gray Sheet" - March 29, 2010

FDA should have no reason to rescind 510(k) substantial equivalence decisions for marketed devices except in extreme cases of fraud, device industry lobbyists said in recent comments to FDA. Read more...

Device Stakeholders Debate Whether FDA Can, Or Should, Revoke 510(k)s

Article reprinted from "The Gray Sheet" - March 29, 2010

FDA should have no reason to rescind 510(k) substantial equivalence decisions for marketed devices except in extreme cases of fraud, device industry lobbyists said in recent comments to FDA.

The agency has raised the question of its rescission authority as part of a broader reassessment of the 510(k) program.

FDA is seeking public input on what circumstances, if any, might justify FDA's rescinding its own 510(k) clearance decision. Comments on that question, among several others, were due March 19 (see sidebar: " More 510(k) Reform Fears: Condition of Clearance Studies, GMPs? ").

FDA Claims "Limited" Rescission Authority

Fundamentally, there is a question of what authority the agency has to rescind a 510(k). FDA statutes provide explicit authority to the agency to withdraw a PMA or investigational device exemption in certain situations, but no analogous language for 510(k)s.

As Heather Rosecrans, head of the device center's 510(k) staff, recently characterized it, FDA has "limited" but not "robust" authority to rescind a 510(k).

The CDRH staffer highlighted a few instances in which FDA nullified a 510(k) clearance at FDA's Feb. 18 public meeting to discuss issues with the 510(k) program (The Gray Sheet' Feb. 22, 2010).

Past clearances were revoked when the agency discovered false information material to substantial equivalence, or when the agency uncovered new information that raised substantial questions about device safety and effectiveness, Rosecrans said.

A 2001 proposed rule that would have made FDA's 510(k) rescission authority explicit was never finalized, she noted (The Gray Sheet' May 18, 2009).

But in questions posed in a Jan. 27 Federal Register notice, FDA asked stakeholders to consider what rescission authority would be appropriate "without regard to current law."

Device trade group AdvaMed argued that "absent the commission of an act of fraud in establishing the substantial equivalence of a device, rescission would not be justified."

Otherwise, expanding FDA's rescission authority would do "more harm than good," the group said in March 19  comments to the agency.

Use Other Post-Market Tools - AdvaMed

FDA should not rescind a 510(k) just because it was manufactured under poor conditions that affect its safety and effectiveness, or because a manufacturer changes the device's design, AdvaMed said.

Instead, the agency should use other means to remove problematic devices from the market, such as banning the product, mandating a recall or ordering a product seizure, the trade group suggested.

The Medical Device Manufacturers Association (MDMA) also maintained that FDA lacks the statutory or regulatory authority to rescind a 510(k) clearance, adding that "such authority is not necessary to address safety concerns."

MDMA agreed that the only reason for seeking 510(k) rescission authority would be to address fraudulent submissions.

In such cases, the data supporting the 510(k) submission would have to be "grossly falsified so as to mischaracterize the device," device maker Siemens suggested in March 5 comments.

AdvaMed emphasizes that rescinding 510(k) decisions would create problems for all marketed devices claiming substantial equivalence to that product.

CDRH's Rosecrans acknowledges that FDA is worried about the "domino effect" of rescinding a 510(k) clearance.

AdvaMed says using other enforcement authorities to isolate and remove a 510(k) device that should not be on the market will still prevent the device from being used as a predicate in the future "because it would no longer be a 'legally marketed product.'"

Others Call For Broader Rescission Authority

But other groups support more authority for the agency to revoke a 510(k).

"If information is obtained to indicate that the safety and effectiveness of a product have been compromised, FDA should be able to rescind pre-market clearance in a timely manner," the BlueCross BlueShield Association wrote March 17.

The insurer noted that a lack of stronger post-market tools "is one of the most substantial deficiencies of the 510(k) program."

The American Association for Justice, representing trial lawyers, urged FDA to finalize its previously abandoned 510(k) rescission rule, allowing for rescissions in "a wide array of circumstances," including the emergence of new safety data regarding adverse events associated with the device, fraud in the clearance process and problems with the underlying data used to clear the device.

Rescission Questions Arise In Menaflex Re-Review

The matter is of potentially urgent interest to one company, ReGen Biologics, whose knee implant is undergoing an unprecedented re-review by FDA.

FDA has not specifically threatened to rescind ReGen's Menaflex 510(k) if the agency determines that it erred in its 2008 clearance of the product.

Nor has the agency laid out precisely how it will proceed if it determines that a PMA and not a 510(k) was needed.

"The final steps depend on our final conclusion," CDRH Director Jeff Shuren said following a March 23 advisory panel meeting to reassess the Menaflex clearance.

FDA plans to issue a decision on the Menaflex re-review in the "coming weeks".

- Jessica Bylander

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