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.