On 25 May 2026, the FDA added the sixth edition of ISO 10993-1 (November 2025 edition) to its list of recognised consensus standards under recognition number 2-313. This standard, which forms the basis for the biological evaluation of medical devices on the US market, replaces the previously applicable fifth edition from 2018. The change affects every manufacturer that refers to ISO 10993-1 in their premarket documentation, and in practice covers the vast majority of devices that come into direct or indirect contact with the patient’s body.
What does ISO 10993 cover and what does it not cover?
ISO 10993-1 specifies the requirements and general principles for the biological safety assessment of medical devices as part of a risk management process in accordance with ISO 14971. The scope of the standard covers devices that come into direct or indirect contact with the patient’s body under conditions of intended use or foreseeable misuse, as well as devices intended for personal protection, such as medical gloves or surgical masks, which come into contact with the bodies of users who are not patients. The biological evaluation takes into account risks arising from both the components of the device and tissue-device interactions, including physical effects. The standard explicitly excludes from its scope the assessment of risks associated with infectious agents, i.e. bacteria, viruses and TSE agents. These issues are regulated by a separate series of standards. It is also important to note that the standard does not require the retesting of devices already on the market for which there is an established and acceptable safety profile.
Partial recognition: which provisions does the FDA not accept?
The FDA recognises the sixth edition only partially. Two elements of the standard have not been recognised. The first is the wording concerning consumer products contained in clause 6.5.11.3. This conflicts with published FDA guidance (Appendix G to the guidance of September 2023), according to which not all materials used in consumer products are acceptable in medical devices. The second excluded element is clause 6.9 concerning the assessment of biological risk, which the FDA considers inconsistent with its own approach to risk management described in clauses 5.5, 6 and 7 of ISO 14971:2019. The latter remains the overarching standard for the FDA in this area. Manufacturers declaring conformity with ISO 10993-1:2025 should clearly state in their documentation that these two elements are not covered by the declaration.
What should be taken into account when implementing the sixth edition?
The FDA highlights two areas requiring particular caution in a note accompanying the entry. Firstly, the ISO TC194 WG1 committee is currently developing technical reports on the application of ISO 10993-1:2025 with regard to intermittent contact, bioaccumulation, foreseeable off-label use, and assessment throughout the product’s life cycle. The FDA recommends contacting the relevant review office before commencing a biological evaluation based on these provisions, as the published technical reports may provide further clarification. Secondly, the additional requirements for genotoxicity assessment set out in Tables 2, 3 and 4 and in Section 6.5.7 of the standard may not be fully consistent with Table A.1 of Annex A of the FDA guidance for devices intended for prolonged contact; this discrepancy requires individual discussion with the review office prior to submission of the premarket application.
Transition period
The inclusion of the sixth edition on the list does not imply an immediate obligation to apply it. The FDA will accept declarations of compliance with the fifth edition of ISO 10993-1 (2018 edition, reference number 2-258) in premarket submissions until 1 July 2029. After that date, declarations referring to the fifth edition will not be accepted. The three-year transition period gives manufacturers time to update their biological evaluation procedures, adapt their Biological Evaluation Plans (BEPs) and review existing biocompatibility reports in light of the new requirements. However, it is advisable not to leave this review until the last minute, as the sixth edition introduces substantive changes that may require the documentation to be supplemented or, in certain cases, additional testing to be carried out.
Implications for the European market
Although the FDA’s decision applies solely to pre-market documentation in the US market, the sixth edition of ISO 10993-1 will also be of significant importance to manufacturers seeking MDR certification. The standard was developed by an international ISO committee. Manufacturers pursuing parallel certification in the US and EU markets should plan the process of updating their biological assessment now in a way that allows for consistent reference to the sixth edition in the ‘ ’ of both regulatory systems, thereby avoiding the need to maintain separate documentation pathways for each.
Source: FDA Recognised Consensus Standards – Medical Devices, FR Recognition Number 2-313