FDA Announces Proposal to Amend Product Jurisdiction Regulation – A Bit Better But Not Good Enough

By Jeffrey N. Gibbs & Jennifer M. Thomas — On May 15th, FDA published in the Federal Register a proposal to amend the product jurisdiction regulation (21 C.F.R. Part 3). This proposal seeks to update, clarify, and streamline the product classification and designation process.  However, the proposal fails to address some significant flaws in the product jurisdiction and classification decision process. FDA’s product classification and jurisdiction decisions tend to create conflict between Agency and product sponsors because the costs associated with securing marketing authorization can differ significantly based on a product’s classification. In general, device jurisdiction is favored by manufacturers. One of the most significant changes proposed by FDA is to remove the regulatory provision requiring sponsors to seek reconsideration by the Office of Combination Products (“OCP”) (21 C.F.R. § 3.8(c)), before they can appeal a…

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