Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
CDRH inspections database: Center launches 1database Sept. 30 of CDRH-led medical device inspections from 2008 to present. Inspections handled primarily by the Office of Regulatory Affairs are not included in the searchable database, so the database provides access to about 25% of device inspections conducted in the past two years. CDRH leads inspections of foreign facilities, as well as inspections related to Medical Device Reporting, labeling and software issues. The database can be found on the CDRH Transparency website. Clinical trial inspections are not included "because information about new medical device development is confidential," CDRH notes
You may also be interested in...
FDA Device Center Names New Deputy Policy Director
Almost a year after Nancy Stade stepped down as deputy policy director, Lauren Silvis has been named to take on the role, which is critical to developing CDRH policy, especially as the agency is pursuing a paradigm shift in premarket data requirements.
Regulatory News In Brief
510(k) modifications guidance
Regulatory News In Brief
510(k) modifications guidance