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U.S. Department of Health and Human Services

Medical Devices

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Frequently Asked Questions on Establishment Registration Fees and Electronic Registration and Listing for Medical Device Establishments

Effective FY2013 (October 1, 2012) the requirements for medical device establishment registration and listing will change. Please see Medical Device Establishment Registration and Listing - Notice of Changes for FY 2013 for important information.

Frequently Asked Questions about the New Device Registration and Listing Requirements
 
Please contact reglist@cdrh.fda.gov for further information.

The following questions and answers provide information about electronic registration and listing.

How do I retrieve my password to register electronically?

If you have forgotten your password to access the electronic registration and listing system, you may attempt to reset your password by using the following steps:

  • Visit the FDA Industry Systems page at https://www.access.fda.gov/oaa/
  • Click on the “Forgot Your Password” link
  • Enter your Account ID, select a secret question, enter the answer and click on the “Continue” button

If you answered the question correctly, your password will be reset and sent to you by email. If you did not answer correctly, or you did not provide an answer to a secret question before, then you will have to contact the Registration and Listing staff and ask that your password be reset. To do this, please send an email to reglist@cdrh.fda.gov. Include in that email the following information:

  • Your Name
  • Name of establishment
  • Registration number (unless not yet assigned)
  • Owner Operator number for establishment
  • Account ID
  • A request that the password be reset
  • Your contact phone number (if you are a domestic firm)

Please note that the process to reset a password may take up to 7 business days. Your new password will be sent to you via email.

Where can I get assistance if I have any questions?

For assistance you may contact us at:

Email: reglist@cdrh.fda.gov

Or

You may also contact the Division of Small Manufacturers, International and Consumer Assistance at:

Email: dsmica@cdrh.fda.gov
Phone: 301-796-7100 or 800-638-2041