Update to 4 FDA Data Elements for ACE Entries

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Per CSMS #16-000210:

 

Please be advised that that FDA will temporarily allow submission of ACE entries without transmission of four (4) data elements currently listed as mandatory in the FDA Supplemental Guidance document.

 

 

The four impacted data elements are:

• Intended Use Code,

• Brand Name,

• Device Listing Number (LST), and

• Active Ingredient Producer (Entity Role Code “GD”)

If filers are unable to obtain this information at the time of transmission, a value of “UNK” (unknown) will be allowed to assist in the transition from ACS to ACE.

Beginning April 4, 2016, in addition to the syntax currently listed in FDA’s Supplemental Guide:

• UNK will be a valid syntax for Intended Use Code.

• UNK will be a valid syntax for PG07 Brand Name.

• UNK will be a valid syntax for description of Affirmation of Compliance “LST.”

• Entity role code “GD” is temporarily not required for the Active Ingredient Producer.

FDA will be hosting a webinar to review the technicality of these temporarily changes on March 23, 2016. To attend please register here.

Please note: FDA requires the information associated with these four data elements in order to make an admissibility decision. Failure to transmit the complete information, including a value of “UNK”, will result in CBP rejecting the entry. If the correct information or UNK is provided, FDA may request documentation and further information about the entry. FDA highly encourages filers to transmit complete data sets, including Intended Use, Brand Name, Device Listing Number, and Active Ingredient Producer, when required by the specific commodity. Filers that transmit complete information will receive priority review of entries and an expedited review process.

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Finally, on a related note, there is an FDA webinar on March 29 about on the status of the ACE/ITDS pilot (with a focus on Animal and Veterinary products, and Biologics), which provides the opportunity to learn how to prepare and participate in the pilot.  Details here.  [March 22, 2016 Update:  The March 23rd FDA ACE Webinar on the Change to Four Data Elements in the FDA Supplemental Guide, has reached capacity and registrations are now closed. A recording of the webinar will be available here within 3-4 business days after the event: ]

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