FDA proposes attachment of identified polymers to ISO 10993-1

The US FDA is putting forward a proposal to include an attachment with identified synthetic polymers and fabrics in the international ISO 10993-1 Standard on Biocompatibility Evaluation of Medical Devices.

Many devices have intact skin contacting materials that are made from common polymers and fabrics with a long history of safe use in medical devices. In a selected update of the ISO 10993-1 Standard, FDA proposes to include an attachment listing specific device materials for which biocompatibility testing should not be required based on their previous safe use.

Furthermore, FDA recommends introducing a statement in which manufacturers can document that based on the type of materials and nature of contact, biocompatibility risks for their device are addressed in such a way that biocompatibility testing is not necessary. This approach is to rely on relevant quality systems and other post-market controls.

The purpose is to ease the process of assessing the biocompatibility risks and to support the principles of reducing animal use in testing when feasible.

The FDA draft guidance document was issued on 15 October 2020 and is open for comments for a limited period.

For more information on biocompatibility, please contact:

Brian Svend Nielsen
Tel +45 4516 9140