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Comments and Feedback

We welcome your comments about CDRH and its Internet site.  Email is normally reviewed Monday-Friday from 9 a.m. - 4 p.m. EST, except for federal holidays.  Due to the number of responses we are receiving, we cannot acknowledge each one, however we will consider all comments and suggestions.  If you have a medical question, you may wish to visit the Health Information section of the National Institutes of Health home page or the Health Topics area on the CDC web site.  

MANUFACTURERS : Use this link to submit comments relating to medical devices/radiation emitting products regulatory policies, guidance documents, forms and other publications to the Divison of Small Manufacturers, International and Consumer Assistance (DSMICA). Their Email address is DSMICA@CDRH.FDA.GOV.  You may also contact them by telephone, Monday through Friday from 8:00 AM to 5:00 PM, Eastern Standard Time at 1-800-638-2041 or 301.443.6597.  DSMICA's Mailing Address is:
FDA/CDRH/OCER/DSMICA (HFZ-220)
1350 Piccard Drive
Rockville, MD 20850-4307 U.S.A.		 Comments
CONSUMERS : Use this link for consumer questions, suggestions or other feedback about the programs, policies or procedures of CDRH. You may also call the Consumer Staff of the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) by dialing 1-800-638-2041 (Email DSMICA@cdrh.fda.gov) Comments
MAMMOGRAPHY : Use this link for questions about MQSA Accreditation, Certification, Inspections, Policy, Guidance, and other mammography related concerns.  You may also call the Mammography Facility Hotline at 1-800-838-7715 or FAX your comments to 1-410-290-6351. (Email MQSAhotline@SSSI.net) Comments
REUSE : Use this link to send a question to FDA on the reprocessing and reuse of SUD's  (Single Use Devices) (Email: Reuse@cdrh.fda.gov) or you may call 301-443-2436 Comments
INTERNET/WEB : Use this link to submit feedback about opening documents, downloading, CDRH databases or the CDRH website in general. (Email WEBO@cdrh.fda.gov) Comments

Note: CDRH cannot comment about devices or other medical products that are in the review process. We cannot comment about when a device may be approved or if it will be approved.

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Updated July 8, 2004

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