Life Sciences

FDA eliminates baseline reports

Device Regulation Alert: Safety, Compliance and Reimbursement News, June 23, 2008

An FDA direct final rule will eliminate the need to prepare and file baseline reports regarding medical devices.
 
Currently, manufacturers are required to file baseline reports with the first adverse event report for a device and then update those baseline reports annually. The baseline report includes the FDA product code, the device’s shelf life, the device identifier, and the basis for marketing the device.
           
The FDA proposes eliminating the baseline reporting requirement because the data is also provided in individual adverse event reports required on FDA Form 3500A The direct final rule becomes effective October 27, unless the FDA receives significant adverse comments regarding the elimination of the baseline reports. Comments are due by August 27. A significant adverse comment is one that explains why the change is inappropriate or challenges the premise supporting the rule change.         

In case significant adverse comments are received, the FDA issued a companion proposed rule at the same time as the final rule—setting up procedure to finalize the rule with appropriate comment and response period. Both the final rule and companion proposed rule were published in the June 13 Federal Register.

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