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U.S. Department of Health and Human Services

Medical Devices

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FDA Device Establishment Registration and Listing Update - May 2009

Two major events will be impacting the Center for Devices and Radiological Health (CDRH) at the end of May 2009.

  1.  CDRH will be relocating this summer to the FDA White Oak campus located in Silver Spring, MD. The Center began moving on May 15, 2009, and all staff should be located at the new campus by July 31, 2009. 
  2.  The FDA website will be changing. Through collaboration with users in testing site-wide designs, FDA will be making improvements that will allow you to find information more quickly and will also be easier to use.

 Questions & Answers

 How should I contact CDRH staff during this transition time?
All office addresses, phone and fax numbers will change. So the best way to reach CDRH staff is by email. Our email address is not changing and is still: reglist@cdrh.fda.gov

 What will be the best way to get to Registration and Listing information?
Our new home page can be found by visiting the Medical Device home page, then selecting Compliance Activities (under Program Areas), then Device Registration and Listing. In addition, we will continue to send you information via email, so it is critical that your email address in the FDA Unified Registration and Listing System (FURLS) be kept up-to-date.

 How can I find other information on the website?
If there are Registration documents you routinely use and cannot find on the new site, please contact reglist@cdrh.fda.gov and we will assist you. If you have questions about other FDA information on the website or how to locate other FDA staff, you can contact our industry assistance staff at: DSMICA@fda.hhs.gov or 1-800-638-2041.

 What about the Device Facility User Fee website? Is there still a link to access it?
Yes, information on User Fees and the Device Facility User Fee website is available by clicking on the Fees and Payment link on the Device Registration and Listing home page.

 Will I still be able to search for Registration information on the new website?
Yes, the search engines will not be moving and their addresses will remain the same. The Registration and Listing database address is: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm

 What if I still have questions or need help?
If you have any questions about your account or about device registration and listing, please contact us at reglist@cdrh.fda.gov. Copies of this newsletter can be found by selecting the Document link on the Registration and Listing website.

Theresa McDonald
Chief, Regulatory Policy and Systems Branch
Division of Risk Management Operations
Office of Compliance
Center for Devices and Radiological Health