US: FDA issues guidance on ISO 10993-1 for the biological evaluation of medical devices
The U.S. Food and Drug Administration (FDA) has issued a guidance document on the use of ISO 10993-1 in the assessment of medical devices that come in direct or indirect contact with the human body.
The standard is recognized by the FDA and can be used to demonstrate compliance with the FDA’s safety requirements in premarket applications, humanitarian device exceptions and investigational device applications to the agency.
The guidance includes new considerations such as the use of risk-based approaches to determine if biocompatibility testing is needed. Meditrial regulatory and clinical experts can support sponsors through all phases of risk management and ensure compliance to ISO 10993-1 and FDA standards.
Meditrial can support sponsors and device manufacturers with:
- SOP generation
- Risk management file development
- Risk analysis / software risk analysis
- Risk assessment/ evaluation / control
- Verification of efficacy
- Implementation of feedback from PMS during all life-cycle phases of the medical device development, production, verification and validation, post-market
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For more details please see the guidance from the FDA.
Contact Meditrial for immediate assistance in Europe or the US.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
