FDA issues draft guidance on exclusion of certain materials from biocompatibility testing

The US Food and Drug Administration (FDA) has published draft guidance to propose select updates to its biocompatibility recommendations, to assist manufacturers in preparing premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, investigational device exemption (IDE) applications, premarket notification (510(k)) submissions, and De Novo classification requests for medical devices that come into direct contact or indirect contact with the human body, to determine the potential for an unacceptable adverse biological response resulting from contact of the materials of the device with the body.

Many devices have intact skin contacting materials that are made from polymers and fabrics. FDA believes that these materials pose a very low biocompatibility risk because they have a long history of safe use in medical devices that contact intact skin. For such devices, significant FDA review resources are expended to obtain sufficient rationales to justify omission of biocompatibility testing for frequently used intact skin contacting medical devices, consistent with FDA’s recommendations in its 2020 Biocompatibility Guidance.

This document describes a least burdensome approach for these devices that recommends specific material information to be included in a premarket submission in lieu of biocompatibility testing. This approach also supports the principles of the “3Rs,” to reduce, refine, and replace animal use in testing when feasible.

• Devices included in this policy should meet all of the following characteristics:
  “Medical devices that contact intact skin surfaces only,” as described in section 5.2.2 (a) of ISO 10993-1:2018: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
• Limited (≤24 hour), prolonged (>24 hours to 30 days), and long-term (>30 days) durations of contact, including repeat use devices, and
• Composed of materials outlined in Section III.A(2) of the guidance.