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# Proposed Wound Product Rule Draws Fire
- URL: https://www.fdaweb.com/proposed-wound-product-rule-draws-fire/
- Published: 2024-02-28T12:00:00.000Z
- Updated: 2026-09-14T14:24:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156442

Stakeholders are expressing concerns about an FDA 11/30/2023 proposed rule on medical device wound products. The DuVal & Associates law firm [says](https://www.regulations.gov/comment/FDA-2023-N-3392-0081?ref=fdaweb.com) the proposed rule “imposes requirements on wound product clearances/approvals to address an unsubstantiated concern. The proposed rule addresses the issue of antimicrobial resistance and its impact upon the microbiota in a precipitous, unsubstantiated, overbroad, and unnecessary fashion. We surmise what FDA is really saying, without disclosing it publicly, is there are some large-scale regulatory changes it wants to make with wound products, but FDA is hindered by its past administrative proceedings and findings with respect to wound products…. FDA is using the administratively created idea that antimicrobial wound products are a problem to antimicrobial resistance and its alleged effects on the microbiota to justify adding new burdensome regulations. Both premises are unsubstantiated.”

The letter summarizes these points it hopes the agency will consider:

- FDA is undermining, and effectively rewriting, the 510(k) process by removing legally cleared claims from wound product devices and effectively requiring legally marketed devices to perform additional testing to retain existing statutorily cleared claims;
- given that wound products have been on the market for more than five decades, FDA is effectively performing a *de facto* reclassification without a basis for the change that is grounded in valid scientific evidence as required by the Federal Food, Drug, and Cosmetic Act;
- based on the evidence supplied by FDA, the establishment of specific special controls has not been demonstrated to be appropriate and necessary to provide a reasonable assurance of the safety and effectiveness of the device;
- under the proposed rule, the agency has not abided by the statutory procedural requirement that the proposed rule be published sooner than six years following a 2016 panel recommendation; and
- the impact on patients will be extraordinary since the increased burden placed on manufacturers will result in companies pulling products from the market and allocating resources away from innovation.

Integra Life Sciences [proposes](https://www.regulations.gov/comment/FDA-2023-N-3392-0072?ref=fdaweb.com) separate rules for the various wound dressings and washes that are the subject of the proposed rule, delineated by the level of antimicrobial resistance concern and risk to patient health for each product. It also requests clarification of the regulatory framework and testing requirements and recommends extension of the compliance effective dates and removal of the provisions to limit intended use claims.

The Consumer Healthcare Products Association [asks](https://www.regulations.gov/comment/FDA-2023-N-3392-0064?ref=fdaweb.com) that FDA clarify how products that are currently unclassified and that are not within the scope of the proposed rule would be regulated when the proposed rule is finalized. It also asks for clarification on how products that are currently marketed under specific product codes and that are not within the scope of the proposed rule will be affected by the finalization of the proposed rule. It further asks for several additional clarifications.