This resource is the US FDA (Food and Drug Administration) guidance on applying ISO 10993-1 to the biological evaluation of medical devices within a risk management process. It is one of the most important references for the biocompatibility section of FDA submissions.
About this document
The guidance explains the extent to which the FDA recognises ISO 10993-1 and its additional requirements, including determining evaluation endpoints by nature and duration of contact, when testing may be waived, sample preparation requirements and how to organise the biocompatibility evaluation report.
Applicable products and users
- All medical devices that contact the body of patients or users
- Companies submitting 510(k), De Novo, PMA or IDE applications to the FDA
Main contents
- The risk-based biological evaluation process
- Evaluation endpoints by type and duration of contact
- Conditions for citing material data from legally marketed devices
- Recommended format for biocompatibility testing and evaluation reports
Download
Related articles
- FDA: The Complete Compliance Path for Biocompatibility Submissions for Medical Devices
- US FDA Medical Device Registration Services
Need help interpreting this document or assessing its impact on your product? EVERBIZ provides regulatory consulting and registration services – please contact us.
Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.