miércoles, 30 de diciembre de 2015

CDRH Industry: Announcing Draft Guidance on Public Notification of Emerging Postmarket Medical Device Signals

Today the FDA released a draft guidance document Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). This document proposes a policy for how the FDA will notify the public about medical device “emerging signals.”
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. 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. Because of the evolving nature of this information, FDA would be sharing it with the public at an early stage of the Agency’s assessment and evaluation of the signal.
We welcome your comments and suggestions regarding this draft guidance. Submit comments to www.regulations.gov, using the docket number FDA-2015-D-4803. The comment period will be open for 60 days.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

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