Our Website Uses Cookies
We and the third parties that provide content, functionality, or business services on our website may use cookies to collect information about your browsing activities in order to provide you with more relevant content and promotional materials, on and off the website, and help us understand your interests and improve the website.
For more information, please contact us or consult our Privacy Notice.
Your binder contains too many pages, the maximum is 40.
We are unable to add this page to your binder, please try again later.
This page has been added to your binder.
- Home
- News and Insights
- Insights
- FDA Announces Proposed Rule to Require Veterinary Device Submissions to Customs and Border Protection’s Automated Commercial Environment
FDA Announces Proposed Rule to Require Veterinary Device Submissions to Customs and Border Protection’s Automated Commercial Environment
August 5, 2020, Covington Alert
On Monday, FDA published for public comment a proposed rule concerning the submission of certain data elements for veterinary devices imported or offered for import via the Automated Commercial Environment (ACE) or other U.S. Customs and Border Protection (CBP)-authorized electronic data interchange (EDI) system.[1] Comments are due by October 19, 2020.
The proposed rule would add veterinary medical devices to the list of other imported FDA-regulated products for which the data elements 21 C.F.R. § 1.72 requires must be submitted at the time of entry. The required data elements would include: (1) FDA Country of Production; (2) complete FDA Product Code; (3) full intended use code; and (4) importer of record telephone number and email address. FDA advises that submission of these data elements in ACE would help FDA to more effectively and efficiently make admissibility determinations for veterinary devices by increasing the opportunity in FDA’s Operational and Administrative System for Import Support (OASIS) system for automated “May Proceed” determinations for veterinary device entries. These are the same data elements that must be submitted for the electronic filing of entries containing food contact substances, drugs, biological products, HCT/Ps, medical devices for human use, radiation-emitting electronic products, cosmetics, and tobacco products.
For purposes of the proposed rule, a veterinary device is a “device” as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act that is intended for use in animals.
If you have any questions concerning the material discussed in this client alert, please contact the following members of our Animal Food and Drug practice
FDA Publishes Draft Guidance Proposing to Establish Standardized Assay Limits for Medicated Feeds
February 26, 2020, Covington Alert
Today, the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) published a draft Guidance for Industry (draft guidance) proposing to standardize assay limits for medicated feeds. CVM requests electronic or written comments concerning the draft guidance be submitted to the docket by April 27, 2020. The draft guidance recommends a standardized ...
February 14, 2020, Covington Alert
On February 13, 2020, the Food and Drug Administration (FDA) issued a draft guidance document describing the pre-submission consultation process for food additive petitions (FAPs) and generally recognized as safe (GRAS) notices for ingredients used in animal feed/pet food, and describing what to include in food use authorization (FUA) requests. The Animal Drug ...
November 27, 2019, Covington Alert
Last week, the United States Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) published Draft Guidance for Industry No. 256, “Compounding Animal Drugs from Bulk Drug Substances” (Draft Guidance).