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U.S. Department of Health and Human Services

Medical Devices

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Annual Medical Device Establishment Registration Extended

 

Dear Association Representative,
 
The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) is extending the annual medical device establishment registration period for fiscal year 2013 (FY2013) by one month. The FY2013 annual registration period that was scheduled to end on December 31, 2012, will now end on January 31, 2013.  
 
Today FDA issued the below letter to all medical device registered establishments. 
 
Thank you for your support.
 
Food and Drug Administration
Center for Devices and Radiological Health
 
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Dear Medical Device Establishment:
 
The purpose of this letter is to notify you that the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) is extending the annual medical device establishment registration period for fiscal year 2013 (FY2013) by one month. The FY2013 annual registration period that was scheduled to end on December 31, 2012, will now end on January 31, 2013. This means that an establishment may renew its registration through January 31, 2013.
 
The registration period is being extended to allow industry more time to comply with the new requirements of 21 CFR 807 and the Medical Device User Fee Amendments (MDUFA III) contained in the FDA Safety and Innovation Act (PL 112-144).
 
Electronic Registration System Enhancements
 
To facilitate registration under the new requirements, CDRH upgraded the FDA Unified Registration and Listing System (FURLS) Device Registration and Listing Module (DRLM) and will add additional enhancements during December 2012. Specifically by December 17th, upgrades to DRLM will support:
 
  • the upload of spreadsheets to identify importers of foreign devices for each listing, and
  • the upload of a single spreadsheet containing proprietary names for all of an establishment’s device listings.
 
In addition, by the end of December 2012, DRLM will permit the identification of those products that are being offered for import by a foreign establishment, but are not yet imported into the United States. It will also allow foreign manufacturers that do not ship products directly to the United States to identify the registered foreign establishments that purchase their products for export to the United States.
 
Delays in Responding to Voice Mails and Emails to the Registration and Listing Office
 
With the new annual registration requirements that have taken effect this year, CDRH has received a larger-than-usual number of inquiries than expected and we are making every effort to respond as quickly as possible. However, delays have been running from five to ten business days. If you are waiting for a response from CDRH, please allow two weeks before contacting us again.
 
Thank you for your patience.
 
Sincerely,
 
David Gartner, Chief
Regulatory Policy and Systems Branch
Division of Risk Management Operations
Office of Compliance
Center for Devices and Radiological Health

 

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