On December 31, 2015, FDA announced the availability of the draft guidance document, Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”) for comments. The draft guidance would allow FDA to publish new postmarket information about a medical device that has not yet been analyzed for its impact on the overall benefit-risk ratio. This client briefing provides more details of the implications of this guidance.
The draft guidance document was published for commenting purposes only, and does not establish any rights or requirements for anyone, and is not binding on FDA or the public. Comments are accepted on this draft guidance document until February 29, 2016. Interested parties can comment electronically on regulations.gov, or send their written comments to FDA at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
Make sure to cite Docket Number FDA-2015-D-4803 when sending written comments about this draft guidance document.