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# Concerns About FDA Drug/Device Reclassifications Aired
- URL: https://www.fdaweb.com/concerns-about-fda-drug-device-reclassifications-aired/
- Published: 2021-11-30T12:00:00.000Z
- Updated: 2026-09-14T17:24:02.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5150665

Stakeholders are contacting FDA to express opposition to or concerns about the agency’s recent reclassification of drug products as drug-led combinations whose components require additional regulatory review.

The Association for Accessible Medicines (AAM), representing the generic drug industry, is calling on the agency to rescind its reclassification decision. In a strongly-worded 11/22 comment [letter](https://downloads.regulations.gov/FDA-2021-N-0843-0021/attachment%5F1.pdf?ref=fdaweb.com), AAM says the agency announced the reclassifications without giving applicants prior notice or an opportunity to be heard and subjected scores of products that previously were classified as drugs to significant new regulatory requirements.

“It was not necessary to reclassify these products under FDA’s authorizing statute or regulations, nor does case law demand it,” AAM says. “We are concerned that the abrupt decision to do so, without warning and in a way that unduly burdens pending and approved applications, will harm patients.”

AAM says it appears that the agency’s sole reason for making the reclassifications is the belief that they were called for in a DC Circuit Court of Appeals decision in *Genus Med Techs v. FDA*. But, it says, “the assertion that *Genus* requires FDA to alter the longstanding regulatory framework for these products is incorrect.”

AAM says the appeals court took pains to emphasize that nothing in the statute or the court decision compels FDA to regulate the individual components of combination products either as “drugs” or “devices” in their own right. “Indeed,” it says, “*Genus* could not have been clearer in holding that FDA has ‘flexibility to regulate component parts of combination products as either ‘drugs’ or ‘devices’ even though such products include both drug and device elements.”

The association says that once the reclassifications are rescinded, FDA should “remedy the harms those decisions have inflicted on AAM’s members by expediting agency review and action on the applications that have been derailed by this sudden change of course and refrain from making further reclassification decisions until the agency has reviewed the comments in its open post-*Genus* docket and complied with the Administrative Procedure Act’s rulemaking requirements.”

The Advanced Medical Technology Association (AdvaMed) [says](https://downloads.regulations.gov/FDA-2021-N-0843-0020/attachment%5F1.pdf?ref=fdaweb.com) it supports products being regulated appropriately and gives some suggestions for FDA to consider if products currently regulated as drugs are transitioned to devices. AdvaMed says the agency should provide multiple opportunities for public comment and transparency in the transition process.

Its comments cover general considerations for products under review, already approved/marketed, and in development; determination of device classification; challenges in transitioning from one quality management system to another; labeling and promotion considerations; and user fee implications.

On behalf of several affected clients, Foley & Lardner says the reclassifications will significantly affect the pharmaceutical industry due to the time and effort needed to navigate a new device regulatory landscape. Its [comments](https://downloads.regulations.gov/FDA-2021-N-0843-0026/attachment%5F1.pdf?ref=fdaweb.com) address FDA regulation of certain contrast agents; the impact of requiring drug/device combinations to meet Quality System regulations; classification of drug/device combinations going forward; FDA requirements for pending NDAs for ophthalmic drug/device combinations; FDA requirements for approved NDAs for ophthalmic drug/device combinations; and inspection requirements for drug/device combination products.