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  1. Device Advice: Comprehensive Regulatory Assistance

FDA Onsite Registration and Listing Verifications

FDA Onsite Registration and Listing Verifications

The FDA has contracted the services of Dun & Bradstreet to conduct onsite verification of medical device facility information provided to the agency by registered and listed medical device manufacturers. As part of these services, Dun & Bradstreet may look to verify information such as a facility’s Data Universal Numbering System (DUNS) disclaimer icon, various addresses, establishment type, and products.

Dun & Bradstreet may also contact firms not registered with the FDA that the agency has learned may be involved in the manufacture of medical devices.

Participation is voluntary—if Dun & Bradstreet contacts your facility, we ask for your full cooperation so that we can verify your facility’s information is accurate. By cooperating with these efforts, you help us save you time and expense.

If you are contacted and you want to confirm the legitimacy of the verification request, please ask to see the requestor’s Dun & Bradstreet identification.

Additionally, if your firm has general questions regarding this initiative, please contact the FDA at  FDACSI@fda.hhs.gov