Certification for IRB Professionals (CIP) Practice Exam

Is exempt category 2 subject to FDA regulation?

1. Yes

2. No

3. Only if it involves drugs

4. Only under specific conditions

The correct answer is: No

Exempt Category 2 refers to certain products or actions that are not subject to the same regulations as other categories under FDA oversight. Specifically, those in Exempt Category 2 typically involve products that are not considered to pose a significant risk to public health or safety, which means they do not fall under the strict regulatory framework of the FDA. This category allows for more flexibility and fewer regulatory burdens for manufacturers and certain practices that meet specific criteria. In essence, the regulation is aimed at ensuring that the FDA's resource allocation focuses on risks that are more likely to affect health outcomes for consumers. In contrast, other categories, particularly those involving drugs or high-risk medical devices, are subject to stringent FDA oversight to ensure safety and efficacy. The other options suggest conditional regulations, but the nature of Exempt Category 2 clearly indicates a broader exemption from such regulations altogether.