We use cookies to deliver our online services. Details of the cookies we use and instructions on how to disable them are set out in our Cookies Policy. By using this website you agree to our use of cookies. To close this message click close.

FDA finalizes long-awaited Medical Device Data Systems rule

23 February 2011

Medical Device Alert

On February 15, 2011, the Food and Drug Administration (FDA or the Agency) issued a long-awaited final rule reclassifying Medical Device Data Systems (MDDS) as class I, 510(k)-exempt, medical devices. The final rule comes almost three years after the Agency's February 8, 2008, issuance of a proposed rule seeking to classify MDDS as class I, 510(k)-exempt.

Read "FDA finalizes long-awaited Medical Device Data Systems rule"

The team

Loading data