FDA Proposes Public Notification of “Emerging Signals”

| Printer friendly version

The Food and Drug Administration has proposed a new policy for earlier public notification of medical device safety issues.  These notifications will be in addition to the recall notices, safety communications, and press releases the FDA already puts out.

In the proposed guidance, which is not yet final, the FDA notes the “need to notify the public about emerging signals that the Agency is monitoring or analyzing, even when the information has not been fully analyzed, validated, or confirmed, and for which the Agency does not yet have specific recommendations.”  However, the FDA notes that “[p]osting this information does not mean that FDA has concluded there is a causal relationship between the medical device and the emerging signal.  Nor does it mean that the FDA is advising patients or health care professionals to discontinue or modify use of these products.”

Examples of emerging signals given in the guidance include: “a newly recognized type of adverse event associated with a medical device, an increase in the severity or frequency of reporting of a known event, new product-product interactions, device malfunctions or patient injuries potentially related to improper device use or design, or a reduction in benefit to the patient.”

In the guidance, the FDA notes that a decision to issue a public communication about an emerging signal should only come when:

  • the information represents a new, potentially causal association, or a new aspect of a known association (e.g., increased rate or severity of even or reduced benefit), between a medical device and one or more adverse events or clinical outcomes;
  • the available information is reliable and supported by sufficient strength of evidence; and
  • the information could have important clinical implications for patient management decisions and/or could it significantly alter the known benefit-risk profile of the device.

The guidance outlines that once an emerging signal is communicated, updates to the communication should be posted to the FDA website at least twice per year until a more formal and finalized communication is issued.

Comments on the proposed guidance should be submitted by February 29, 2016, to ensure consideration.  Instructions on how to submit comments can be found here.

 

 

April White
April White is an associate in our San Diego office. Prior to joining the firm, Ms. White attended law school at the University of San Diego School of Law. While in law school, Ms. White was an editor for the San Diego Law Review. Prior to her legal education, she received a Bachelor of Science in Mechanical Engineering from the University of Louisville. Ms. White joined the firm in 2015.
Click here to read full bio
View all posts published by April White »

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.