Regulatory Affairs Certification (RAC) Practice Exam

What regulatory action must a U.S. company take to export a Class III medical device to Australia?

1. Apply for a new NDA

2. Send a Simple Notification to FDA and obtain an 802 Certificate of Exportability

3. Request pre-market approval from the FDA

4. Conduct a clinical trial in Australia

The correct answer is: Send a Simple Notification to FDA and obtain an 802 Certificate of Exportability

To export a Class III medical device to Australia, a U.S. company must engage in specific regulatory actions that comply with both U.S. FDA requirements and Australian Therapeutic Goods Administration (TGA) regulations. Sending a Simple Notification to the FDA and obtaining an 802 Certificate of Exportability is the correct course of action because this certificate demonstrates compliance with the FDA's export requirements for products that are not approved for commercial distribution within the U.S. The 802 Certificate of Exportability indicates that the device meets the necessary regulatory standards for export, even if it hasn't undergone the full approval process in the U.S. This facilitates the process of legally exporting the device while providing assurance to foreign regulatory authorities, like the TGA, of adherence to necessary safety and efficacy standards. This action allows the U.S. company to proceed with their exportation efforts with the appropriate documentation, reducing risks associated with non-compliance during international distribution.