Senior Regulatory Counsel

0910-AH66 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices

The FDA is issuing a direct final rule and a companion proposed rule to require that certain data elements be submitted to Customs and Border Protection and FDA for veterinary devices to ensure that FDA has adequate information to determine admissibility. This rule ensures that the regulations on import submissions for veterinary devices are the same as for all other FDA regulated products.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage Undetermined Undetermined Fully or Partially Exempt 21 CFR 1.17 21 CFR 1.72 21 CFR 1.75 21 U.S.C. 371 21 U.S.C. 381 No Direct Final Rule 10/00/2018 Undetermined Undetermined Undetermined No No Randall Gnatt Senior Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7231 randall.gnatt@fda.hhs.gov Center for Veterinary Medicine, 7519 Standish Place, MPN-4, Room 168, HFV-200, Rockville MD 20855