Dear Manufacturers of Cardiovascular Devices,

 

We are writing to tell you that review of 30-day notices for cardiovascular devices has moved from CDRH’s Office of Compliance to the Office of Device Evaluation. 

 

Beginning February 1, 2013, all 30-day notices for manufacturing changes to Class III cardiovascular devices that were previously reviewed by CDRH’s Office of Compliance will be reviewed by the Office of Device Evaluation, Division of Cardiovascular Devices. This will not affect your submissions or timeframes. This transition was previously discussed at the FDA Public Workshop held in August 2012 (http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm312205.htm).

 

Under the FD&C Act and 21 CFR 814.39(f), changes in manufacturing procedures or methods of manufacture that affect the safety or effectiveness of a device require a 30-day notice. A guidance document issued on April 13, 2011, entitled “30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes” outlines FDA's current thinking on which types of changes may qualify for a 30-day notice. The guidance document can be found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080192.htm

 

Food and Drug Administration