Strengthening Medical Device Safety

FDA has announced a new program that is designed to transform and strengthen medical device safety.

This initiative will work toward an electronic reporting system and is expected to provide unique ways to identify medical devices including standardized and globally accepted names. Information in patient records about device information will be improved as will collaboration on post market safety issues. Using collaborative efforts with professional organizations and the industry, opportunities to improve the safety of medical devices are expected.

This initiative is the result of a year-long internal inventory of the tools used to monitor the safety of medical devices after they are approved by the FDA. The inventory identified many areas that are working well but also identified challenges associated with medical devices post-market.

Click here to obtain a copy of CDRH’s Medical Device Postmarket Safety Program or Medical Device Postmarket Safety Program – Synopsis and Recommendations