Archives: Administrative Procedure Act

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Court Rejects FDA’s Interpretation of the Statute’s Device Definition as “Erroneous and Unreasonable”

The United States District Court for the District of Columbia, in Prevor v. FDA (Prevor II), rejects for the second time FDA’s “erroneous and unreasonable interpretation” of the definition of “device” under the Federal Food, Drug and Cosmetic Act (FDCA) (op. at 21).  The court has remanded the case to FDA to use a lawful standard … Continue Reading

D.C. District Court Rules FDA has Inherent Authority to Rescind 510(k) Clearance in “Rare Situation”

In a closely watched case, Ivy Sports Medicine v. Sebelius, et al., the United States District Court for the District of Columbia recently upheld FDA’s rescission of the clearance of ReGen Biologic’s 510(k) for the Menaflex Collagen Scaffold device (Ivy Sports Medicine is the successor in interest to ReGen).  The court held that FDA has … Continue Reading

Cytori v. FDA: D.C. Circuit Upholds FDA’s NSE Decisions

Stating that it was “ill-equipped to second-guess” FDA’s scientific judgments, the D.C. Circuit Court of Appeals recently upheld FDA’s determination that two medical devices were not substantially equivalent to a legally marketed predicate device.  The case, Cytori Therapeutics, Inc. v. FDA, highlights the uphill battle that companies face when challenging scientific decisions made by FDA. … Continue Reading
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