For veterinary devices being imported or offered for import into the United States, and where entry is electronically filed in the Automated Commercial Environment or any other electronic data interchange system authorized by U.S. Customs and Border Protection, this proposed rule would require the submission of certain data elements material to FDA's process of making decisions on admissibility. This proposed rule therefore would simply extend to veterinary devices the submission of the data elements that are currently required for other FDA-regulated products at the time of entry.

Cost savings would result from increased efficiency in, and streamlining of, FDA's imports admissibility process. These cost savings to the industry and FDA cannot be quantified because FDA currently lacks data to do so. Potential benefits to consumers, that we are similarly unable to quantify, would result from a reduction in the number of non-compliant veterinary device imports reaching U.S. consumers and from compliant imported veterinary devices reaching U.S. consumers faster.

The FDA has estimated the annualized costs of complying with this proposed regulation to be between $0.028 million and $0.073 million per year (using 3 and 7 percent discount rates). These costs were already previously inadvertently included and the benefits were discussed in the regulatory impact analysis (RIA) for the “Submission of Food and Drug Administration Import Data in the Automated Commercial Environment” final rule. We tentatively conclude that this proposed rule would have no additional costs beyond the costs that were included in that RIA.

Federal Register: 85 FR 46566 – August 3, 2020

Docket: FDA-2018-N-4268