Select Updates for Biocompatibility of Certain Devices in Contact With Intact Skin; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin." FDA has developed this draft guidance to propose select updates to FDA's current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that are in contact with intact skin. This draft guidance is not final nor is it in effect at this time.