Court Rules that FDA has the Inherent Authority to Rescind a 510(k) Substantial Equivalence Determination if It Does so Within a Reasonable Period of Time

By Carmelina G. Allis –

As we previously reported, ReGen Biologics, Inc. ("ReGen"), which has been acquired by Ivy Sports Medicine, LLC ("Ivy"), filed suit in 2011 challenging FDA’s authority to rescind the 2008 510(k) substantial equivalence determination for the company’s “Menaflex” product, a collagen meniscus implant intended to reinforce damaged meniscal soft tissue.  ReGen Biologics, Inc. v. Sebelius, No. 1:11-cv-01006 (D.D.C. filed May 31, 2011). 

The 510(k) clearance for Menaflex classified the device into Class II.  In October 2011, FDA rescinded the 510(k) substantial equivalence determination alleging that the device does not have the same intended use as the predicate devices.  By rescinding that classification, pursuant to Section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act ("FDC Act"), the product is now classified as a Class III device subject to the more stringent premarket approval ("PMA") requirements.

The company argued in the U.S. District Court for the District of Columbia that FDA lacks legal authority under the FDC Act to rescind a 510(k) substantial equivalence determination.  Because the rescission resulted in a reclassification of the device from Class II to Class III, ReGen argued that FDA should have complied with the reclassification procedures in 21 U.S.C. § 360c(e).  The procedures in § 360c(e) require that the agency secure an advisory panel recommendation and a publication in the Federal Register of a recommendation regarding the device’s classification prior to reclassifying the device.

Instead, FDA administratively rescinded the 510(k) substantial equivalence determination after conducting a review of the agency’s records in the matter.  The agency concluded that the record shows that FDA decision-makers departed from administrative processes, procedures, and practices, which resulted in a failure to document and explain the bases for the substantial equivalence determination, and also resulted in misconduct that affected the integrity of the administrative process.

FDA argued in court that it acted properly within its inherent administrative authority.  And the court agreed.  District Judge Robert L. Wilkins ruled that FDA has the inherent administrative authority to reconsider and change a 510(k) substantial equivalence determination in these circumstances if it does so within a reasonable period of time, even if the agency could have invoked a statutory provision to achieve the same result.  Ivy Sports Med., LLC v. Sebelius, No. 11-cv-1006 (D.D.C. Apr. 10, 2013).

In this case, the court agreed with FDA that the administrative record was “tainted.”  Examples given by the court of procedural irregularities and misconduct include:

• The agency’s failure to respond appropriately to external pressure on decision-makers – for example, FDA allowed Ivy to meet with agency officials without members of the review team present, and allowed members of Congress to speak directly to the Commissioner and Principal Deputy in violation of agency usual procedures.
• The exclusion of individuals, if not viewpoints, from parts of the scientific debate – for example, the court found that the company was successful in excluding the review team from speaking at the panel meeting.  The court explained that such exclusion could have skewed the panel meeting discussion in Ivy’s favor, and also did not allow the panel members to consider the reviewers’ concerns.
• The excessive reliance on advisory panel deliberations – for example, the court found inappropriate that the agency based its decision “entirely or almost entirely on the views of an outside Panel,” even though those views were in conflict with those of the FDA reviewers and the decision-making documents did not address the reviewers’ concerns.  Moreover, the panel meeting was convened with such “haste” that there was little time for panel members to properly prepare on the substantial equivalence standard or FDA’s panel procedures, and key panel members could not participate.

See id. at 17.

The court also found that FDA acted within a reasonable period of time when only eight to ten months passed between the initial agency determination of substantial equivalence to when the “affected party received notice that the determination was ‘actively under reconsideration,’ not when the agency made its final decision.”  Id. at 26-27.  In this case, FDA classified the device via the 510(k) substantial equivalence determination in December 2008.  The agency then began its review of the record in April 2009, published a preliminary report in September 2009, and met with the company in October 2009 to inform them of the administrative review.  The court ruled that this time period of eight to ten months “falls comfortably within the reasonableness standard.”  Id. at 27.

Ivy also argued that the FDA acted arbitrarily and capriciously because it did not limit its review of the substantial equivalence determination on the intended use statement of the device as set forth in the proposed labeling submitted in the 510(k).  According to the court’s opinion, FDA reviewed the indications for use and instructions for use of the Menaflex and predicate devices, and the directions for preparation of the surgical site of the Menaflex and predicate devices.  The agency also considered comments from panel members on the use of the Menaflex – such as statements that they were “‘having trouble with comparing’” the Ivy device with predicate devices because they “‘really aren’t used in the same way,’” and they “‘expressed uncertainty about what the [Ivy] device is intended to do.’”  Id. at 29.  The court ruled that “there is nothing improper about” “looking beyond the Indications for Use Statement” submitted in the 510(k) even though that is not “‘[t]ypically’ what is done.”  Id.

The court also found that FDA’s determination to rescind the 510(k) is based on a “review of the relevant material, including an examination of both panels, meetings with the review team, and the overall record,” and further concluded that the agency “properly based [its] conclusion on the [Ivy] device’s proposed labeling.” Id. at 31.

In sum, FDA has always asserted that it has the inherent authority to rescind 510(k)s.  It would be a mistake to infer from this decision support for the proposition that FDA may administratively rescind a 510(k) clearance simply because new or different agency officials arrive at a different scientific or policy judgment than their predecessors.  However, this decision does appear to affirm FDA’s rescission authority if the agency gives notice of reconsideration in a reasonable time frame and if there is evidence in the record of fraud and/or other misconduct affecting the integrity of the original decision.