FDA’s Partial Recognition of ISO 10993-1:2025

What to Know and How to Prepare

FDA’s May 2026 partial recognition of the recently released ISO 10993-1:2025 standard has important implications for medical device manufacturers. Partial recognition means that the FDA has not accepted certain portions of the new ISO standard, even as it endorses the bulk of it. Regulatory affairs professionals and biocompatibility experts must understand these exceptions, adjust their biological evaluation plans accordingly, and clearly address them in premarket submissions. Below, we explain what partial recognition means in practice, detail which clauses FDA did not recognize (and why), outline the transition timeline from the 2018 to 2025 edition, and offer practical guidance for navigating this change.

How to Present Partial Recognition in Your Device Submissions

FDA’s standards recognition program allows manufacturers to declare conformity to consensus standards in submissions to streamline review. When the FDA “recognizes” a consensus standard fully, sponsors can submit a Declaration of Conformity stating their device meets that standard in full, potentially reducing the need for detailed supporting data on those aspects. However, “partial recognition” indicates FDA does not accept one or more parts of the standard; those parts either conflict with FDA requirements or require separate justification. Sponsors may still leverage ISO 10993‑1:2025, but they cannot rely on the excluded clauses to claim conformity in their FDA regulatory submissions. Partial recognition means a full Declaration of Conformity is not possible without caveats. Ensure your submission documentation calls out the partial recognition and demonstrates compliance via alternative means for the non-recognized aspects. This proactive clarification can prevent deficiency questions from FDA.

FDA Excluded Clauses

First, the FDA does not recognize the phrase “consumer products or” in Clause 6.5.11.3. This clause deals with assessing material safety, and it references materials used in “consumer products” as possibly not needing the same level of scrutiny in a biological evaluation. Attachment G of FDA’s 2023 biocompatibility guidance provides a list of specific material types that FDA generally considers low risk for intact skin devices (e.g., certain well characterized polymers and natural fabrics). With few exceptions (i.e., color additives), other processing chemicals and additives included in these materials do not necessarily need to be disclosed in marketing submissions for devices with this type of tissue contact, regardless of duration. Manufacturers should not assume the material is safe for a device just because it’s used in a consumer product. Instead, refer to FDA biocompatibility guidance, Attachment G, to consider whether the material is listed. Manufacturers need to have sufficient evidence to support the materials used in the final, finished device are safe considering the influences of manufacturing and other processes on the device materials.

Second, FDA does not recognize Clause 6.9 Biological risk estimation. This clause introduces a methodology for assessing the overall biological risk of a device (possibly separate from general risk management) suggesting that after identifying hazards, one should estimate the remaining biological risk. FDA prefers to manage biological risks under ISO 14971:2019 (the recognized risk management standard) rather than a separate risk scoring approach as presented in ISO 10993-1. For FDA submissions, manufacturers should integrate biological risk evaluation into the overall risk management file. Use ISO 14971’s framework to identify and mitigate biocompatibility-related risks (e.g., by listing biological hazards in your risk analysis and controlling them via material selection, testing, etc.). Do not attempt to use any separate risk scoring or estimation process from ISO 10993‑1:2025 Clause 6.9 in lieu of ISO 14971. FDA will expect to see biological risks addressed according to ISO 14971 (Hazard analysis, FMEAs, etc.) rather than a new standalone scoring.

FDA’s Additional Notes and Clarifications

New Risk-Based Concepts: FDA has provided two additional notes in its recognition listing: Note 1 points out that ISO TC194 WG1 (the ISO biocompatibility working group experts) is developing technical reports on implementing ISO 10993-1:2025, covering topics such as intermittent contact, bioaccumulation, reasonably foreseeable misuse, and medical device life cycle application. These reflect new risk-based concepts in the standard. For example, ISO 10993‑1:2025 elaborates on daily vs. intermittent contact (how repeated short uses over days count as cumulative exposure) and bioaccumulation of device constituents over time. It also brings “reasonably foreseeable misuse” into the biological evaluation (aligning with both ISO 14971 and EU MDR expectations) and stresses evaluating biocompatibility throughout the device’s entire life cycle (from design to disposal), not just at first use. FDA’s note essentially cautions that these areas are new and under discussion. Manufacturers are encouraged to consult FDA reviewers about how to implement these concepts in their submissions, since the standard’s guidance is fresh and being refined.

Genotoxicity Testing: Note 2 highlights a potential misalignment between ISO 10993-1:2025 and FDA’s own guidance regarding genotoxicity evaluation for prolonged-contact devices. It should be noted that the FDA’s 2023 biocompatibility guidance does not require genotoxicity testing for the following device categories: 1) Devices with prolonged mucosal contact, 2) Devices with prolonged contact with breached or compromised surfaces, and 3) Devices with indirect, prolonged contact with the blood path. By contrast, the updated tables presented in ISO 10993‑1:2025 suggest genotoxicity evaluation for all prolonged exposures (with some conditional language). FDA’s note clarifies that manufacturers might not need to conduct genotoxicity tests for those device categories because the FDA’s own guidance exempts them. This will be helpful for certain device manufacturers by avoiding unnecessary genotoxicity testing, thereby reducing testing burden, timelines, and costs while remaining aligned with FDA expectations without compromising safety. FDA encourages manufacturers to discuss any genotoxicity test plans for prolonged-contact devices with the FDA in advance, especially if the ISO standard would appear to require it but FDA might not. This proactive communication ensures you don’t over-test or under-test relative to FDA expectations.

Timeline for Transition

FDA recognition of ISO 10993‑1:2025 (6th edition) will supersede the 2018 edition. FDA will continue to accept declarations of conformity to ISO 10993‑1:2018 in premarket submissions until July 1, 2029. After this date, declarations of conformity to the 2018 edition will no longer be accepted, and sponsors should reference ISO 10993‑1:2025, noting its partial recognition. This long transition window (over 3 years from the standard’s publication) acknowledges that manufacturers may need significant time to update internal processes, re-train staff, and perhaps generate new data to meet the updated standard’s concepts. For devices nearing submission or currently in development, there is some flexibility – manufacturers can decide to stick with the 2018 edition for now (still recognized by FDA) or proactively adopt the 2025 revision. For long-term product plans or new devices where submissions will occur in 2029 or beyond, it’s wise to begin aligning with ISO 10993‑1:2025 now. Notably, even if you continue using the 2018 edition in the near term, you should familiarize your team with the changes in the 2025 revision – many principles (like integrating risk management and focusing on cumulative exposure) are relevant best practices already. Early adoption can also demonstrate to FDA reviewers that your approach is forward-looking and risk based.

Practical Guidance: Managing Partial Recognition – What to Do Now

1) Targeted Gap Assessment: Compare ISO 10993‑1:2025 against your current practices. Focus on the new or changed recognized requirements, ensure gaps are explicitly identified and adjust your biological evaluation plan and Declarations of Conformity accordingly. Ensure your Biological Evaluation Plan/Report aligns with the 2025 edition’s recognized clauses and note any differences from your previous practices. Document how each new requirement will be met or why it doesn’t need to be met, especially where partial recognition might imply alternative handling. This forms the basis of your updated compliance strategy.

2) Device Categorization & Cumulative Exposure: Ensure your device’s contact classification is up to date. The 2025 revision emphasizes cumulative exposure over multiple uses. Make sure your device’s contact classification reflects worst-case use scenarios. Consider whether repeated or prolonged use might elevate the contact duration category (refer to “contact days” in the new revision) or introduce bioaccumulation concerns. Align these details with ISO 10993‑1:2025’s definitions to identify any new risk considerations.

3) Leverage Existing Biocompatibility Evidence: Before initiating new tests, use available information to fill gaps. For any new requirements or identified gaps, check if existing data (e.g., material SDSs, technical data sheets, chemical characterization results) already demonstrate safety. This can reduce additional testing, provided the evidence is robust and aligns with FDA’s 2023 biocompatibility guidance.

4) Integrate Risk Management: Make sure the risk management file explicitly covers biocompatibility risks in line with ISO 14971. Cross-reference the biological evaluation with overall risk assessments to show FDA a cohesive picture. Simultaneously, routinely consult FDA’s 2023 biocompatibility guidance for specifics on what FDA expects. Where the new ISO standard goes beyond or differs from FDA guidance (like genotoxicity for prolonged contact), defer to FDA guidance or seek FDA feedback to resolve discrepancies.

5) Engage with Experts Early: Don’t hesitate to consult with biocompatibility experts on how to interpret the new standard’s provisions. Moreover, use FDA’s Pre-submission (Q-Sub) process or other channels to ask questions if you’re unsure about how to handle something like intermittent contact or genotoxicity requirements in your specific case. FDA’s recognition notes literally invite manufacturers to reach out to review offices about implementing the new clauses. Early dialogue can clarify expectations and prevent delays or surprises in premarket submissions.

Detailed discussion of these changes is covered in our earlier MED blog posts on key updates in the 2025 revision.

Part 1: Reasonably Foreseeable Misuse

Part 2: Exposure Duration

Part 3: Biological Effects

Part 4: Material Characterization

Part 5: Genotoxicity

MED Institute provides comprehensive biological risk assessment services to support the safety evaluation of medical devices in accordance with ISO 10993 and related regulatory requirements. Contact us today to discuss your project needs 855.463.1633 | askmed@medinstitute.com | medinstitute.com.

Special thanks to Dr. Andrea Agree, PhD, RAC-Devices, RCC-MDR, RCC-IVDR for coauthoring this article.