FDA Proposal Seeks to Shine Early Spotlight on Postmarket Device Safety Concerns
The US FDA has released a proposal to speed up how it reports emerging signals of problems with medical devices that are already on the market.
According to an email announcement from the agency’s Center for Devices and Radiological Health (CDRH) on New Year’s Eve, the intent is to share evolving information at an early stage.
“Historically, the FDA has communicated important medical device postmarket information after having completed an analysis of available data and, in most cases, after having reached a decision about relevant recommendations for the device user community and about whether further regulatory action is warranted,” the CDRH says. “However, we believe there also is a 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.”
Unlike a device safety communication, any reporting at these early stages may lack certainty about clinical significance and details on whether the issue is new, stems from a causative association, or is related to a known problem, the draft guidance cautions. But timely communication can enable healthcare providers and the public to make informed treatment decisions, encourage better reporting of events, and reduce the number of patients exposed while a potential risk is being investigated.
Comments and suggestions about the proposal can be made via www.regulations.gov, using the docket
number FDA-2015-D-4803, through February 29, 2016.
Food and Drug Administration. Public notification of emerging postmarket medical device signals (“emerging signals”): draft guidance for industry and Food and Drug Administration staff. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm479248.pdf. Published on: December 31, 2015. Accessed on January 4, 2016.