Will FDA Withdraw Its Wound Care Device Rule? Stakeholders Sure Hope So…

So, I had some free time today and decided to work with AI on an assessment of comments submitted to FDA’s November 2023 Proposed Rule (the “proposed rule”) to classify antimicrobial wound dressings and washes.

The final rule was slated to be published in May 2026, and though that time has passed, the absence of a withdrawal notice, or any other information on FDA plans, is undoubtedly disconcerting to the wound care community.

The project included various prompts and refinements on my part, and time reviewing and confirming or adjusting inferred or borderline findings manually. The proposal, for those who don’t know, aims to create new device classifications covering hundreds of currently marketed antimicrobial wound dressings—devices that primarily incorporate ingredients like hypochlorous acid or silver, have been staples of wound care for decades, and have excellent safety and efficacy profiles.

The stated rationales FDA put forward for the proposed rule were twofold: (1) to address antimicrobial resistance concerns (based on a disputed theory that use of antiseptic dressings and washes could meaningfully increase antibiotic resistance), and (2) to add regulatory clarity to wound dressing and wound wash regulation. The problem with the proposal is that, if finalized, it would likely do the opposite by helping to accelerate antibiotic resistance and throwing a stable and well-established regulatory regime into chaos.

Per commenters, the final rule could well bring about substantial disruptions in wound care for particularly vulnerable patients—as noted in this comment on the proposed rule—along with other scientific, policy, and legal concerns, including inadequate economic analyses of the rule’s impact as required under the Regulatory Flexibility Act.

As far as numbers, here were 76 unique comments submitted to the docket of the proposed rule. Here is a breakdown of the sentiment:

Docket FDA-2023-N-3392: Wound Dressing and Wound Wash Proposed Rule Public Comment Sentiment Analysis
Source: regulations.gov bulk export + attachment review  |  Analysis date: June 2026
Sentiment	Count	% of Total	Notes
Strong Opposed	58	76.3%	Advocating for withdrawal, highlighting major disruptions in patient care, and/or questioning scientific rationale for proposed changes
Opposed in Part	14	18.4%	Objected strongly to application to certain specific antimicrobial products, and/or other proposed elements (e.g., confusing and unnecessary labeling restrictions) but did not have the broad level reflect with Strongly Opposed Sentiment
Supportive	2	2.6%	Supports FDA’s proposed reclassification and approach
Unclassified	2	2.6%	Position could not be determined
TOTAL	76	100.0%
(77 Comments were posted but one was a duplicate form the some submitter)

The 95 percent of stakeholders with negative sentiment about the rule includes physicians, researchers, medical societies, large and small medical device companies, and various broad-based collectives covering the full stakeholder community, like the Alliance for Wound Care Stakeholders. Unsurprisingly, when agencies like the Office of Management and Budget (OMB) and the Department of Health and Human Services (HHS) announced a request for information for deregulatory actions, the Alliance requested withdrawal of the proposed rule in line with stakeholder sentiment and recommendations.

Given the broad-based criticism of the proposed rule on all fronts—and the general consensus that reforms were unnecessary and likely to harm to medical care—the proposed rule should be an ideal candidate for withdrawal consistent with deregulatory initiatives. However, finalization of the proposed rule was added to FDA’s regulatory agenda, as mentioned, with a goal to publish a final rule in May 2026.

As the comment period to the proposed rule is closed, there is no way to make additional comments on the matter. So, what can be done in situations like this?  A helpful approach stakeholders can take is keeping agencies apprised of continued interests and concerns in matters and reminding them of substantial concerns raised. This can bring light to a topic, especially with the current turnover at federal agencies. Some routes could include emailing the FDA Commissioner’s Office, contacting the Office of Management and Budget, or making deregulation suggestions on the Regulations.gov website (contact information in links).  Talking about the issue at conferences or gatherings to spread the word or reaching out to other government stakeholders in Congress (every congressional office has an email) is also a means to keep attention on important issues—and keep concerns at the forefront of decisionmakers minds, as time passes and administrations and/or management change.

If you have questions, please feel free to reach out to the author.

Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.