On December 31, 2015, FDA-CDRH issued a draft guidance Public Notification of Emerging Postmarket Medical Device Signals. The draft guidance describes FDA’s policy for notifying the public about medical device “emerging signals”. An emerging signal is new information about a medical device used in clinical practice:
- that the Agency is monitoring or analyzing
- that has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device
- that has not yet been fully validated or confirmed
- for which the Agency does not yet have specific recommendations
The draft guidance is available at http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm479248.pdf
The draft guidance is open to public comment at www.regulations.gov
Enter the docket number FDA-2015-D-4803 and you will be able to read all of the public comments.