Dive Brief:
- The Food and Drug Administration has finalized recommendations on the biocompatibility of devices that come into contact with intact skin.
- In the final guidance, the FDA defines which devices and materials are covered by the advice and gives details of the biocompatibility information applicants should include in premarket approval applications.
- The text has undergone some changes since it was released for consultation in 2020, but the FDA has opted against making certain major requested revisions, such as expansion of the text to cover metals.
Dive Insight:
The FDA has provided the new advice in an attachment to an existing document on the use of an ISO standard. It applies to medical devices that contact intact skin, whether for a limited or long time, and are made from synthetic polymers or natural fabrics.
The document provides a list of materials covered by the guidance, as well as a table of devices and materials that are excluded. For example, devices with a metal or adhesive component are not covered by the guidance.
In premarket approval submissions, the FDA expects applicants to include a list of all materials used to fabricate the device, including color additives, plus a statement confirming that the materials have a history of safe use in legally marketed devices that touch the skin.
Other sections of the document cover recommendations for applicants to run clinical trials and seek clearance via routes such as the 510(k) pathway. The FDA also provides advice about the format and content of labels that convey information about the potential for patients to react to materials.
Officials have made small changes to the labeling section, to clarify that the advice applies to products used by healthcare professionals and patients, and revised other paragraphs to explain how the requirements apply to processing chemicals and additives. Most of the text is the same as the draft version.
AdvaMed suggested a more significant revision in its feedback on the draft, proposing the extension of the guidance to cover metals that come into contact with intact skin. However, the FDA has kept metals out of the scope of the final guidance, grouping them with materials that are excluded because they pose known risks or may introduce toxicity risks.