USA – FDA releases guidance documents on biocompatibility submissions and nitinol-containing devices

The US Food and Drug Administration (FDA) has issued two new guidance documents related to premarket submissions on device biocompatibility with intact skin, as well as technical considerations for nitinol-containing devices.
 
In the draft guidance, issued 15 October, the FDA provided select updates on the type of compatibility information that should be included in premarket submissions for devices made from common polymers and fabrics that come in contact with intact skin. The draft guidance outlines the criteria for certain devices made from materials with “very low biocompatibility risk” and a “long history of safe use in medical devices” to bypass biocompatibility testing…