The following is a framework for the development of a biocompatibility evaluation and is not a checklist for testing.

For particular medical devices, different biological endpoints may require evaluation, including either additional or fewer endpoints than indicated. If it is unclear in which category a device falls, the FDA recommends consulting device-specific guidances or contacting the appropriate Center and review division for more information.

For example, the FDA has historically considered devices used to drain fluids (such as Foley catheters) as externally communicating devices rather than as surface devices contacting mucosal membranes.

Note: On this page, FDA’s Biocompatibility Guidance on Use of ISO 10993-1 refers to Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The content on this page comes from this guidance, unless otherwise noted.

Tables: Each of the tables on this page lists biological effects for contact duration periods by specific medical device categorization and nature of body contact. The contact duration periods are:

• Limited Contact: Less than or equal to 24 hours
• Prolonged Contact: Greater than 24 hours to 30 days
• Long-term/Permanent Contact: More than 30 days

Within each table, endpoints are listed by:

• Surface Device
  • Intact Skin
  • Mucosal Membrane
  • Breached or Compromised Surface
• External Communicating Device
  • Blood Path, Indirect
  • Tissue/Blood/Dentin
  • Circulating Blood
• Implant Device
  • Tissue/Bone
  • Blood

Device categorization information can be obtained informally via email, or as a part of the Q-Submission process. Refer to the FDA’s guidance document, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff.

Endpoints for Consideration: The endpoints for consideration listed in the tables include:

• ISO 10993-1:2009 recommended endpoints for consideration
• Additional FDA recommended endpoints for consideration

Refer to FDA’s Biocompatibility Guidance on Use of ISO 10993-1, Attachment A for details on which endpoints are included in ISO 10993-1 recommendations and which are additional FDA recommended endpoints.

Other endpoints (not included in the tables) to be addressed are:

• Reproductive and developmental toxicity: Should be addressed for novel materials, materials with a known reproductive or developmental toxicity, devices with relevant target populations (for example, pregnant women), and/or devices where there is the probability for local presence of device materials in the reproductive organs.
• Degradation information: Should be provided for any devices, device components, or materials remaining in contact with tissue that are intended to degrade.

Limited Contact: Surface Device

Note: Other endpoints you may need to address: Reproductive and development toxicity, degradation information.

Limited Contact: External Communicating Device

Notes:

• Tissue includes tissue fluids and subcutaneous spaces.
• Genotoxicity: For all devices used in extracorporeal circuits.
• Other endpoints you may need to address: Reproductive and development toxicity, degradation information.

Limited Contact: Implant Device