February 6, 2019

FDA Updates Process for Issuing Public Warnings and Notifications of Recalls

February 7, 2019—FDA Commissioner Scott Gottlieb, MD, announced new steps that the agency is taking to strengthen and modernize its process for issuing a public warning about a voluntary recall and for notification of recalls.

The statement from Dr. Gottlieb advised that the FDA has issued its final guidance, to be published February 8 in Federal Register. The guidance outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general time frame for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient.

The guidance also describes the FDA’s policy for moving forward with posting recalls to the FDA’s Enforcement Report, which is a web listing of all recalls monitored by the FDA, in some cases before a final health hazard evaluation is completed. The FDA has begun implementing the recommendations outlined in the final guidance.

Dr. Gottlieb noted that most companies collaborate with the FDA to rapidly initiate voluntary recalls and work with their supply chain partners to remove the product from shelves to prevent further distribution. Recalls generally occur quickly when a problem is discovered. However, there are situations where the FDA may need to provide safety advice to the marketplace to protect consumers.

The FDA routinely provides information on recalls and other safety issue occurrences. Additionally, they frequently communicate directly to consumers through the agency’s social media so that consumers can protect their own health, stated Dr. Gottlieb.


February 8, 2019

Leviticus Cardio and Jarvik Heart Announce First-in-Human Implantation of the Wireless FIVAD System

February 5, 2019

Vectorious Begins VECTOR-HF FIH Trial to Support European Approval of V-LAP Device