Devices

CDRH Releases Learning Module for Corrections/Removals eSubmissions

CDRH has posted a new medical device education module to its CDRH Learnprogram Web site — Electronic Submission of 806 Reports of Corrections and Removals. Under 21 CFR 806, Medical Devices; Reports of Corrections and Removals, manufacturers and importers are required to report any correction or removal of a device if it was initiated to reduce a risk to health posed by the device or to remedy a violation of the act caused by the device which may present a risk to health. The report must be submitted to FDA within 10 working days from the time the firm initiates the correction or removal. Under the module, CDRH:

Introduces a new electronic submission system which generates electronic reports of Corrections and Removals
Shows step-by-step instructions on how to submit a correction or removal action using electronic system
Shows instructions on how to transmit the report via Electronic Submission Gateway

CDRH Releases Learning Module for Corrections/Removals eSubmissions

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