RAPS

FDA updates medical device biocompatibility guidance with exclusion list

The US Food and Drug Administration (FDA) has updated its guidance on biocompatibility issues medical device sponsors should consider in their premarket submissions. This is the second time the agency ...
RAPS

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 ...
MD&M East

New FDA Crackdowns: How Device Makers Can Avoid Costly Mistakes

At the end of 2025, FDA will be revising its guidance on ISO 10993-1, leaving medical device manufacturers to spend the remaining months of the year preparing for regulatory changes. FDA is also ...