## Facts

- A manufacturer obtained FDA 510(k) clearance in December 2008 to market the Collagen Scaffold, an absorbable surgical mesh used in certain knee surgeries, based on a finding of “substantial equivalence” to an existing device.
- The clearance drew media and congressional criticism, including allegations of improper political pressure.
- FDA conducted an internal review and found procedural irregularities in the clearance process.
- FDA did not use the Medical Device Amendments’ reclassification process under 21 U.S.C. § 360c(e), which generally requires notice and an opportunity for public comment.
- Instead, FDA invoked an asserted “inherent reconsideration authority,” re-evaluated the device, and rescinded the 510(k) clearance, effectively forcing the product off the market.
- The manufacturer and its successor, Ivy Sports Medicine, LLC, challenged the rescission; the district court entered summary judgment for FDA.

## Issues

1. Whether FDA may rescind a prior 510(k) substantial-equivalence determination by invoking “inherent reconsideration authority,” rather than proceeding through the statutory reclassification process in 21 U.S.C. § 360c(e).
2. Whether FDA’s rescission, given its regulatory effect, was functionally a reclassification that required notice-and-comment procedures.

## Decision

- The D.C. Circuit reversed the grant of summary judgment to FDA.
- The court held that FDA lacked authority to bypass the statutory reclassification mechanism by rescinding the clearance under an asserted inherent reconsideration power.
- The court directed the district court to vacate FDA’s rescission order and remand to the agency for further proceedings.

## Legal Principles

- When Congress provides a specific statutory procedure for an agency action, an agency generally may not circumvent that procedure by invoking non-statutory “inherent” reconsideration authority.
- Under the medical-device statutory scheme, changing a device’s effective classification after a 510(k) substantial-equivalence clearance must proceed through the reclassification process in 21 U.S.C. § 360c(e), which generally includes notice and an opportunity for public comment.
- An agency action that has the same regulatory consequences as reclassification may be treated as a de facto reclassification requiring compliance with the statute’s procedural requirements.

## Conclusion

The court held that FDA’s rescission of a previously granted 510(k) clearance was unlawful because it effectively reclassified the device without using the statutory reclassification process, and it ordered the rescission vacated and remanded for further proceedings.


Ivy Sports Med., LLC v. Burwell, 767 F.3d 81 (D.C. Cir. 2014)