New FDA Draft Guidance on Medical Devices Would Notify Public of Risk Before Analysis or Confirmation
On December 31, 2015, the FDA released a draft policy which would alter how and, more significantly, when the public is notified of a potential risk associated with a medical device that has already been approved for the market.
Historically, upon receipt of a complaint or information regarding an issue with a medical device, the FDA has undertaken a rigorous analysis of the issue before releasing any information to the public. Because of the time inherent in the collection, analysis and verification of evidence related to a potential safety issue, the FDA has been criticized for failing to timely alert the public to such issues. In an effort to provide more timely notice, the FDA proposes to notify the public upon receipt of information that raises a safety issue with a medical device (an "Emerging Signal") without waiting until that risk can be fully analyzed or verified.
The draft guidance titled, Public Notification of Emerging Postmarket Medical Device Signals,