Today the FDA issued a Technical Amendment that amends certain medical device regulations to update addresses, correct typographical errors, and ensure accuracy and clarity in the Agency’s regulations.
One of the updates changes mailing addresses that previously went to the directors of the Office of Compliance and the Office of Communication, Education, and Radiation Programs at the Center for Devices and Radiological Health (CDRH). CDRH is in the process of building and implementing a new approach to how it conducts business and the way it is structured. As part of this new approach, items previously directed to these office directors will instead be directed to Director, Center for Devices and Radiological Health. These products include:- Diagnostic x-ray systems and their major components;
- Laser products; and
- Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
The full listing of all address changes and other updates can be found within the Technical Amendment.
If you have any questions related to these changes, contact the Division of Industry and Consumer Education at 800-638-2041 or DICE@fda.hhs.gov |
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