On May 25, 2026, the US FDA updated its database of recognized consensus standards (Recognition No 2-313), partially adopting the sixth edition of ISO 10993-1:2025, “Biological evaluation of Medical Devices – Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process”.
The ISO 10993-1:2025 standard specifies the requirements and general principles for the biological evaluation of Medical Devices within a risk management process compliant with ISO 14971, throughout the entire lifecycle of the medical device.
The biological evaluation considers:
- The materials and substances composing the device.
- The interactions between the device and biological tissues.
- The risks associated with the intended use and reasonably foreseeable misuse.
- The changes that can occur during the device’s lifecycle.
Parts of ISO 10993-1:2025 Excluded from FDA Recognition
The FDA has excluded specific provisions of the new edition:
- The phrase “consumer products or” contained in paragraph 6.5.11.3, as this reference conflicts with Attachment G of the 2023 FDA guidance on biocompatibility. In fact, not all materials used in consumer products can be considered appropriate as a reference for the biological safety evaluation of Medical Devices.
- Clause 6.9, “Biological risk estimation”, because it is deemed to conflict with ISO 14971:2019, which is already recognized by the FDA as the reference for medical device risk management. Manufacturers must therefore continue to develop biological risk assessments consistently with the framework provided by ISO 14971.
Genotoxicity: FDA recommends prior consultation
The FDA points out potential critical issues regarding the genotoxicity requirements introduced by ISO 10993-1:2025. Specifically, the Agency highlights that the provisions in paragraph 6.5.7 and Tables 2, 3, and 4 might not be fully aligned with the “Use of International Standard ISO 10993-1” guidance published in 2023, particularly for certain prolonged-contact devices.
For this reason, the FDA recommends consulting with review offices before initiating biological evaluations in more complex cases.
Transition Period
ISO 10993-1:2025 replaces the previous edition ISO 10993-1:2018.
FDA will continue to accept, for the purposes of premarket submissions, declarations of conformity based on ISO 10993-1:2018 until July 1, 2029. After this date, declarations of conformity referencing the 2018 edition will no longer be accepted, and only those based on ISO 10993-1:2025 will be accepted.
Impact on Manufacturers
This update confirms the international convergence toward a biocompatibility approach based on risk management, chemical characterization, and toxicological assessment.
ISO 10993-1:2018 was already harmonized in the European Union and recognized by the FDA; the new 2025 edition strengthens this alignment, despite the limitations mentioned above.
The main shared elements remain:
- Integration of the biological evaluation into the risk management process.
- Chemical characterization as the starting point of the biocompatibility strategy.
- Exposure-based toxicological risk assessment.
- Reduction of animal testing when scientifically justified.
For manufacturers operating in both the European Union and the United States, this update helps make the framework for biocompatibility documentation more consistent, while still requiring careful attention to specific FDA expectations.
Future developments
The FDA notes that the ISO TC 194 WG1 group is developing technical documents on aspects such as intermittent contact, bioaccumulation, reasonably foreseeable misuse, and evaluation across the device’s lifecycle.
For manufacturers, implementation requires a gradual and documented approach, especially for:
- Prolonged-contact devices.
- Innovative materials.
- Complex exposure scenarios.
In the most critical cases, preliminary discussion with the FDA via review offices or the Q-Submission (Q-Sub) program can be highly beneficial to align the biocompatibility strategy before formal submission.
To learn more about the new edition of ISO 10993-1: 2025, read the article.
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