FDA Seeks Public Comment on Manufacturing Deviation Reporting for Biologics and HCT/Ps Used in Wound Care
Key Takeaways
1. This Is a Procedural Notice — Not a New Rule
The announcement falls under the Paperwork Reduction Act and concerns FDA’s renewal of existing reporting requirements. It does not change clinical practice, reimbursement, or product indications.
2. Manufacturing Deviation Reporting Remains a Core Oversight Tool
Manufacturers of biologics and HCT/Ps must report deviations that could impact product safety, purity, or potency. These reports help FDA monitor quality trends and enforce compliance, a critical safeguard for products widely used in wound care.
3. Regulatory Oversight Awareness Matters for CTP Stakeholders
Even when notices are administrative, they reflect the regulatory framework governing CTP manufacturing. Understanding this oversight environment is important for clinicians, compliance leaders, and industry stakeholders navigating an increasingly scrutinized biologics and tissue product landscape.
The FDA has issued a Federal Register notice seeking public comment on the continued approval of reporting requirements for manufacturing deviations involving biologics and human cell and tissue products (HCT/Ps), including many cellular and tissue-based products (CTPs) used in wound care. While the notice does not introduce new regulations, it underscores the agency’s ongoing oversight of product quality, safety, and compliance infrastructure. Stakeholders have until April 27, 2026, to submit comments.
The U.S. Food and Drug Administration (FDA) recently published a Federal Register notice1 seeking public comment on a proposed information collection related to biological products and human cell, tissue, and cellular and tissue-based products (HCT/Ps) used in clinical practice, including wound care therapies. The notice, published February 25, 2026, invites comments on the paperwork burden associated with reporting manufacturing deviations using standardized forms under FDA’s regulatory oversight.
What the Notice Is — and Isn’t
This notice is part of FDA’s ongoing compliance with the Paperwork Reduction Act (PRA) of 1995,2 a federal law that governs how agencies collect information from industry and the public. Under the PRA, agencies must publish advance notice of proposed collections of information and allow at least 60 days for public comment before submitting those collections to the Office of Management and Budget (OMB) for approval.
Importantly, the Federal Register notice does not establish new regulatory requirements for clinicians or manufacturers, nor does it change clinical practice standards or coding policies. Rather, it pertains to FDA’s internal process for renewing or extending approval of an existing information collection that helps the agency monitor manufacturing quality and compliance.
What Information FDA Is Collecting
The focus of the notice is on the reporting of manufacturing deviations for both biologics and HCT/Ps — data that manufacturers are already required to provide under existing regulations. Specifically:
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Biological Product Deviation Reports: Licensed manufacturers must report deviations that may affect the safety, purity, or potency of a distributed biological product, such as vaccines, certain therapeutic proteins, or complex biologic agents. These reports are submitted on Form FDA 3486 in accordance with 21 CFR 600.14 and related rules.3
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HCT/P Deviations: Similarly, manufacturers of human cells, tissues, and cellular and tissue-based products (including many wound care CTPs) must report manufacturing deviations under current good tissue practice (CGTP) regulations (21 CFR 1271), also using Form FDA 3486.2
The forms provide a standardized mechanism for industry to report such deviations and help FDA assess risk trends and compliance with quality systems. Without OMB approval under the PRA, FDA cannot legally continue to require these reports.2
Why This Matters to Wound Care Practitioners
Although the notice itself is procedural, it reflects FDA’s regulatory oversight framework for products that are widely used in wound care, such as allografts, amniotic membranes, and other CTPs. Quality and manufacturing integrity are essential for ensuring patient safety and clinical effectiveness, and FDA’s ability to collect consistent data on deviations supports that oversight role. Reports submitted via Form FDA 3486 allow the agency to:
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Track trends in manufacturing issues that could impact safety or supply
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Target inspections and compliance actions where needed
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Support risk-based regulatory decision-making
Practitioners do not need to submit these forms; compliance responsibilities fall on manufacturers. However, awareness of the reporting infrastructure underscores the interconnectedness between manufacturing controls and clinical outcomes, especially for biologics and tissue-based therapies.
Public Comment and Next Steps
The public comment period for this information collection runs through April 27, 2026. Industry stakeholders — including manufacturers, industry associations, and related organizations — may provide feedback on the estimated burden of the collection and suggest ways to improve clarity or reduce reporting burden. After the comment period closes, FDA will finalize its submission to OMB, which will determine whether to renew the PRA approval.
For clinicians and wound care professionals, this notice is a reminder of the continuing regulatory attention on the quality systems supporting the products they use, even when the notice itself does not directly affect clinical practice.
References
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Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing. Fed Regist. 2026;91(9287):9287-9289. Published February 25, 2026. Accessed February 25, 2026. https://www.federalregister.gov/documents/2026/02/25/2026-03773/agency-information-collection-activities-proposed-collection-comment-request-biological-products
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Paperwork Reduction Act Notices. U.S. Food and Drug Administration. Accessed February 25, 2026. https://www.fda.gov/animal-veterinary/guidance-regulations/paperwork-reduction-act-notices
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21 CFR § 600.14 — Reporting of Biological Product Deviations. Electronic Code of Federal Regulations. Accessed February 25, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-600/subpart-B/section-600.14?
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