lunes, 26 de junio de 2017

CDRH Industry:

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CDRH Learn Announcement

Today, the Food and Drug Administration posted a new medical device education module to the CDRH Learn Program website.

What is CDRH Learn? CDRH Learn is a multimedia catalog of online educational modules intended to provide information about medical device laws, regulations, and policies that is comprehensive, interactive, and easily accessible.  The format for each topic is chosen to present the information in the most effective way possible.  With the addition of this new module, the catalog has grown to over 125 modules.

New Module This new module is located in the "Postmarket Activities" section, Medical Device Recalls subsection of CDRH Learn.

CDRH Learn Module TitleKey Learning Objectives
Electronic Submission of 806 Reports of Corrections and Removals
  • Introduce the new electronic submission system which generates electronic reports of Corrections and Removals
  • Show step-by-step instructions on how to submit a correction or removal action using the “Electronic Submission of 806 Reports of Corrections and Removals” system
  • Show instructions on how to transmit the report via Electronic Submission Gateway (ESG)

Under 21 CFR 806, Medical Devices; Reports of Corrections and Removals, manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device if the correction or removal 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.

Help Us Improve CDRH Learn! Your feedback helps to improve the modules and better serve your educational needs.  After you watch a CDRH Learn module, please take a few minutes to fill out our survey:

For More Information about Medical Devices If you have any questions about CDRH Learn or medical devices, contact the Division of Industry and Consumer Education (DICE):
  • Phone: (800) 638-2041 or 301-796-7100; 9 am- 12:30 pm and 1 pm-4:30 pm Eastern Time
  • Email:
Please visit us at our website for more information about how we may help you.

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