## Facts

- Ivy Sports Medicine, LLC, as successor to ReGen Biologics, manufactured a collagen scaffold medical device marketed as Menaflex, intended to reinforce damaged meniscal tissue and serve as a resorbable scaffold.
- Under the FDCA, medical devices may reach market through premarket approval (PMA) or the streamlined § 510(k) premarket notification pathway, which requires a showing of “substantial equivalence” to a predicate device.
- ReGen pursued FDA authorization for the device for many years, initially through PMA and later through § 510(k); FDA issued multiple “not substantially equivalent” determinations before clearing the device in December 2008 under § 510(k) and classifying it as Class II.
- After the 2008 clearance, FDA investigated concerns that the clearance process involved procedural irregularities and improper influences.
- In March 2011, FDA rescinded the 2008 substantial equivalence determination and changed the device’s classification, effectively removing it from the market unless it obtained PMA as a Class III device.
- Ivy sued federal officials and FDA, challenging the March 2011 action under the FDCA and the Administrative Procedure Act (APA); the parties filed cross-motions for summary judgment.

## Issues

1. Whether FDA had inherent authority to rescind a prior § 510(k) substantial equivalence determination without using the FDCA’s specific statutory reclassification procedures.
2. Whether FDA’s 2011 rescission and resulting classification change was arbitrary, capricious, or contrary to law under the APA.

## Decision

- The court granted FDA’s motion for summary judgment and denied Ivy’s motion.
- The court held FDA had inherent authority to reconsider and rescind a mistaken § 510(k) clearance when exercised within a reasonable time and with appropriate process.
- The court treated FDA’s action as rescission of an erroneous clearance, not a statutory reclassification proceeding requiring use of the FDCA’s reclassification mechanism.
- The court held FDA’s decision was not arbitrary or capricious because the agency identified procedural irregularities, reevaluated the matter, and provided a reasoned explanation supported by the administrative record.

## Legal Principles

- Absent a clear statutory bar, an agency may have inherent authority to reconsider and rescind prior actions if it acts within a reasonable time and affords affected parties adequate notice and opportunity to be heard.
- A rescission of a § 510(k) substantial equivalence determination can be treated as correction of agency error, even if it has the practical effect of changing a device’s regulatory status.
- Under APA review, agency action is upheld when the agency examines relevant information and articulates a rational explanation connecting the facts found to the decision made, with deference to technical judgments in areas of agency competence.

## Conclusion

The district court upheld FDA’s 2011 rescission of Menaflex’s § 510(k) clearance, concluding FDA could rely on inherent reconsideration authority and that the agency’s explanation and process satisfied APA standards.


Ivy Sports Med., LLC v. Sebelius, 2013 WL 1455271 (D.D.C. 2013)