Regulatory Affairs Certification (RAC) Practice Exam 2025 - Free RAC Practice Questions and Study Guide

A medical device can be exported under Section 801(e) of the Food, Drug, and Cosmetic Act as long as certain conditions are fulfilled. The condition related to being 510(k) cleared or PMA approved is not necessary for export under this section.

In international trade, countries often allow the importation of devices that may not meet their specific regulatory approval requirements as long as they comply with the local laws and requirements of the importing country. This provision enables manufacturers and companies to engage in global trade by allowing them to export devices that may not yet have received clearance or approval in the U.S., provided they adhere to the regulatory framework set by the receiving country, including specifications and labeling requirements.

The other conditions—ensuring that the device meets the specifications of the receiving country, does not conflict with their laws, and is properly labeled for export—all help to prevent legal issues and ensure compliance with both U.S. export regulations and the import requirements of the target market. Thus, these provisions are about ensuring that all necessary conditions for legal export are met, without requiring that the device has already obtained FDA approval in the United States for export under this particular legislative section.