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FDA clarifies its policies on publicizing safety issues of approved devices


According to Market Intelligence, December 2022


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FDA clarifies its policies on publicizing safety issues of approved devices

The U.S. FDA issued final guidance on how it shares information with the public on potential flaws in medical devices already on the market, a move that drew criticism from the industry's main lobbying group.

The agency could disclose "emerging signals," including new adverse events, device malfunctions or a reduction in benefit to the patient, according to the Dec. 14 guidance. The signals could come from reports submitted to the FDA, studies conducted after the product has been approved, scientific literature, insurance claims data, patient registries and government investigations.

The FDA said it is trying to improve the consistency and transparency of its communications.
Public notification will be considered when the information supports a causal association between a medical device and adverse event or clinical outcome, the available evidence is of sufficient strength, and the evidence could have important clinical implications or change the benefit-risk profile of a device, according to the FDA.

A decision to provide the public with additional information does not mean the FDA has "definitively concluded that there is a causal relationship between the medical device and the emerging signal," that the agency believes that the use of the device should be limited, or that manufacturers should take specific actions, according to the guidance.

The FDA has already begun issuing the public notifications as outlined in the guidance. For example, in June 2015 the agency informed cardiologists about a potential safety issue related to SynCardia Systems Inc.'s Total Artificial Heart Companion 2 Driver System.

The Advanced Medical Technology Association (AdvaMed) said in an email that it remains concerned that the changes from the December 2015 draft guidance "do not go far enough to mitigate the potential to negatively impact health care providers and patients, creating unnecessary confusion and adverse health outcomes."

The "sweeping" changes to the agency's post-market communication policies "should be accomplished through notice and comment rulemaking rather than through guidance," the lobbying group said.

Finalization of the guidance comes as the FDA is increasing its emphasis on surveillance of devices on the market while trying to approve them faster using approaches such as the Expedited Access Pathway for "breakthrough" medical technology.