Sep 15, 2020

Medical device regulators at the US Food and Drug Administration have clarified guidance on how manufacturers should utilize the ISO 10993 standard for biological evaluations of medical devices.

The updated guidance replaces guidance the agency had finalized in 2016 that emphasized biological evaluations in conjunction with risk management considerations for sterile and non-sterile medical device premarket applications, including 510(k) premarket notifications, Premarket Approvals (PMA) and De Novo requests for designation. The guidance specifically addresses ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.”

Key components of the new FDA biocompatibility guidance

Major elements of the updated final guidance on ISO 10993-1 include the following:

  • Risk assessments for use in biocompatibility evaluations
  • Utilizing ISO 10993-1 along with FDA-specific requirements via an updated FDA-modified matrix to identify and determine biocompatibility endpoints for evaluations of devices
  • Test article preparations and related general biocompatibility testing considerations
  • Testing considerations for particular areas including cytotoxicity, sensitization, implantation and genotoxicity
  • Recommendations for chemical assessments
  • Considerations when device labels include claims that a device is free (“-Free”) of a particular substance

The new guidance also includes various resources for premarket applicants, such as recommendations for what to include in device master files and summary biocompatibility documentation,  plus biocompatibility process flow charts and glossary terms.

Use of related biocompatibility standards for FDA submissions

The guidance notes that FDA may require compliance with additional biocompatibility standards along with or in lieu of ISO 10993-1 for device types for which more specific standards have been established.

For combination products comprising either drug-device or biologic-device components, FDA premarket applicants should adhere to FDA’s guidance on ISO 10993 as well as meet additional or modified testing requirements appropriate for their products.

Learn more about US FDA medical device regulations and biocompatibility requirements:

  • US FDA submission consulting for medical device, combination product and IVD companies
  • Whitepaper: ISO 10993-1 and biocompatibility for medical devices

Author

  • Stewart Eisenhart

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