FDA Issues Draft Guidance with Select Updates for Biocompatibility of Certain Devices that Contact Intact Skin
The FDA has issued the draft guidance Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. This document describes proposed recommendations to assist manufacturers in preparing the following premarket submissions for certain medical devices that come into direct contact or indirect contact with the human body:
- premarket approval applications (PMAs),
- humanitarian device exemption (HDE) applications,
- investigational device exemption (IDE) applications,
- premarket notification (510(k)) submissions, and
- De Novo classification requests (De Novo requests).