FDA’s Partial Recognition of ISO 10993-1:2025: Everything You Need to Know

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

The FDA has officially announced partial recognition of ISO 10993-1:2025, the latest edition of the standard for biological evaluation of medical devices. While this brings greater alignment with international practice, it also introduces important differences between ISO requirements and FDA expectations.

For medical device manufacturers planning US submissions, understanding these differences is essential. Relying solely on the new standard could result in additional regulatory questions, requests for further justification, or unnecessary testing.

The FDA’s Recognised Consensus Standards database was updated on 25 May 2026, providing the long-awaited clarification on where the agency aligns with (and diverges from) ISO 10993-1:2025.

What Does “Partial Recognition” Mean?

When recognition is partial, certain clauses of the standard are excluded or modified, meaning sponsors cannot fully rely on the standard.  

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

• You can use ISO 10993-1:2025 as a framework for biological evaluation .
• You cannot assume all clauses are acceptable to FDA – you should used guidance provided by the FDA as well as Pre-submissions (Q-Subs) to substantiate your biological evaluation process. 
• You must explicitly address any non-recognised elements in submissions.  

Which Parts of ISO 10993-1:2025 Are Not Recognised by the FDA?

FDA’s partial recognition of ISO 10993-1:2025 means, that the FDA excluded specific provisions that conflict with its current regulatory philosophy and guidance: 

1. Clause 6.9 – Biological Risk Estimation

FDA does not recognise Clause 6.9 because it conflicts with ISO 14971-based risk management principles already expected by the agency. 

2. “Consumer Products” Language in Clause 6.5.11.3

The FDA rejected wording that suggests materials used in consumer products may require less scrutiny.  

Additional FDA Concern (“Yellow Flags”) – Genotoxicity Evaluation 

The 2025 edition introduces expanded expectations for genotoxicity assessment, which may not align with FDA’s current guidance, particularly for prolonged-contact devices. 

Clause 6.9 – Biological Risk Estimation

What the standard introduces 

ISO 10993-1:2025 discusses biological risk estimation within the biological evaluation process. It aligns closely with ISO 14971 concepts, discussing: 

• hazard identification 
• hazardous situations 
• harm severity and probability 
• risk estimation specific to biological endpoints 

This defines biological risk estimation as a distinct activity within biocompatibility assessment, rather than something implicitly covered by broader device risk management. 

Why FDA did not recognise it 

FDA rejected Clause 6.9 because it sees potential duplication or conflict with ISO 14971:2019, which it already considers the framework for risk estimation across all device risks – not just biological ones.  

The concern is not that risk estimation is wrong, but that ISO 10993-1:2025 may create a parallel risk estimation structure which could lead to inconsistent methodologies between biological and non-biological risks 

Practical implications 

This is arguably the most impactful exclusion: 

a) No “biological-only” risk estimation framework

You cannot rely on ISO 10993-1’s Clause 6.9 as your primary approach. Instead Biological risks must be estimated using the same framework as all other risks (ISO 14971) 

b) Integration is mandatory – not optional

FDA expects one unified risk file with consistent definitions of severity and probability and alignment between toxicological risk conclusions and overall device risk acceptability 

c) Documentation must show traceability

Reviewers will expect to see a clear link between chemical/toxicological data → hazard → harm → risk estimation. They also expect integration into the device risk management report, not just the BER.  

Clause 6.5.11.3 – Consumer Products Language

What the standard suggests 

Clause 6.5.11.3 includes wording implying that materials used in consumer products may, in some cases, require less rigorous biological evaluation, based on prior widespread human exposure. 

This reflects a broader ISO trend toward leveraging existing safety data, reducing unnecessary testing and enabling justification-based approaches instead of default testing.  

Why FDA rejected this wording 

FDA explicitly does not recognise the phrase “consumer products” in this clause.  

a) Not all consumer exposure equals medical safety

FDA’s position is that consumer product use does not equal medical device safety. The exposure route, duration, and patient population differ significantly.  

b) Hidden risks from additives and processing

Even common materials may contain processing aids, residual monomers and additives (e.g., plasticisers, colorants) which are not necessarily evaluated or controlled to medical device standards. 

c) FDA already defines “low-risk” materials

FDA prefers manufacturers to rely on Attachment G of the 2023 FDA biocompatibility guidance, which lists specific materials considered low risk for certain contact types.  

FDA Concern: Genotoxicity Evaluation

While not formally excluded, FDA raised explicit concern about how genotoxicity is handled in ISO 10993-1:2025. 

What changed in the standard 

The 2025 revision expands genotoxicity evaluation requirements, makes it explicitly required for most prolonged-contact devices (except intact skin) and removes ambiguity present in the 2018 version. 

FDA’s concern 

FDA signalled that the new genotoxicity expectations may not align with its 2023 guidance, especially for prolonged-contact devices. This reflects a recurring issue that ISO tables vs FDA guidance tables are not harmonised. The practical implications are: 

a) Risk of over- or under-testing

Following ISO 10993-1:2025 blindly could trigger unnecessary genotoxicity testing, or miss FDA expectations in certain cases 

b) Increased regulatory uncertainty

Manufacturers may face requests for additional justification challenges to your test strategy 

c) Strong recommendation for early engagement

FDA explicitly encourages pre-submissions (Q-Subs) before initiating genotoxicity programs especially for implants, long-term exposure devices and novel materials.  

Transition Timeline for ISO 10993-1:2025

ISO 10993-1:2025 replaces the 2018 version, but FDA has provided a transition window: 

• Use of ISO 10993-1:2018 allowed until July 1, 2029.
• Increasing expectation to adopt 2025 principles sooner .
• Post-2029: full transition expected.

What Medical Device Manufacturers Should Do Next

FDA’s partial recognition of ISO 10993-1:2025 is not a rejection – it’s a selective alignment. 

It reflects: 

• support for the risk-based evolution of ISO 10993-1.
• insistence on consistency with existing FDA frameworks. 
• caution around areas where global consensus is still evolving.

For manufacturers, success will depend on the ability to: 

• interpret both ISO and FDA expectations together. 
• document rationale clearly. 
• design flexible, scientifically robust biological evaluation strategies. 

Preparing for an FDA submission?

If you’re unsure how FDA’s partial recognition of ISO 10993-1:2025 affects your testing strategy, our specialists can help you plan the right biological evaluation programme before testing begins. Learn more about our biocompatibility services.