Is it acceptable to contact CDRH to get guidance on the meaning of specific requirements of a performance standard or applicable regulation?
Yes. We want you to understand our requirements. We will post the most frequently asked questions to this web site and ask that you look for an answer here or in the guidance and compliance guides that we have already published before you contact us. When you do contact us, please try to be specific about the details of your product and what part of the standard or other regulation is unclear to you.
You may contact CDRH at:
Center for Devices and Radiological Heath
Office of Communication, Education and Radiation Programs
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002