In addition to the normal information required to renew your facility registration this year, there is an additional requirement. Beginning October 1, 2020, the facility’s UFI recognized as acceptable by FDA will be required to be submitted with the registration information (21 CFR 1.232(a)(2)). At this time, FDA only recognizes the Data Universal Numbering System D-U-N-S (DUNS) number as an acceptable UFI.
The DUNS number is assigned and managed by Dun & Bradstreet and is available free of charge. It can be obtained by contacting D&B by one of the ways below:
By phone at 866-705-5711
Via email at firstname.lastname@example.org
By visiting https://www.dnb.com/duns-number.html or https://www.fdadunslookup.com/
As of July 13, 2020, section F2.3 in this https://www.fda.gov/media/85043/download stated that Data Universal Numbering System (DUNS) numbers are currently the only UFI recognized by FDA.
Please reach out to your suppliers and let them know they will need a DUNS number to renew their Facility Registration this year.
Leave a Reply