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Medical device industry responds to FDA proposal to release 'emerging signals' information

by Gail Kalinoski, Contributing Reporter | April 11, 2016
Business Affairs Medical Devices
Manufacturers and trade associations in the medical industry are calling on the FDA to revise a proposal to publicly release information on early safety signals in medical devices before they are investigated, saying it could cause confusion and negatively impact products and patients using them.

The Medical Device Manufacturers Association stated the draft guidance “would not achieve the objectives articulated by the FDA, and in fact, could potentially do more harm than good by providing inaccurate and incorrect data to the public.” The MDMA noted the draft guidance “also lacks clarity when it comes to the threshold of evidence that is required to trigger a particular action.”

The association, and others in the industry, are reacting to draft guidance issued in January by the FDA outlining its proposal to make public information about potential early signs or concerns of a medical device’s safety before the claims have been substantiated. The comment period is coming to a close so trade associations like MDMA and the Advanced Medical Technology Association (AdvaMed), and medical device manufacturers like Abbott, Novo Nordisk Inc., and GE Healthcare recently provided the FDA with their written statements.

Currently, the FDA investigates reports of post-market problems or adverse reactions and issues recall notices, safety advisories, or press releases in most cases after deciding whether further regulatory action is warranted. The draft guidance suggests notifying the public at an early stage of evaluation.

The agency argues that timely communication of a new problem could help health care providers, patients and consumers make informed treatment choices with the most updated information, according to The National Law Review.

“This draft guidance document proposes criteria, time frames, a method of communication, and follow-up for FDA communications for emerging signals,” the FDA stated in its report.

The FDA defines an “emerging signal” as new information about a medical device used in clinical practice that the agency is monitoring or analyzing; has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device; has not yet been fully validated or confirmed, and for which the agency does not yet have specific recommendations.

AdvaMed argued that the draft guidance “represents a significant departure from the Agency’s current post-market communication practices and may not, by FDA’s own admission be in the public interest.”

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