Regulatory Affairs Certification (RAC) Devices 2025 Practice Exam – All-in-One Guide for Exam Success!

The statement that the investigational product must be manufactured in full compliance with current Good Manufacturing Practices (cGMP) is accurate and thus not the correct answer to the question. For both Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs) related to significant-risk products, the manufacturing of investigational products is indeed required to adhere to cGMP regulations to ensure safety and quality. This compliance is a critical aspect of regulatory standards and helps protect subjects during clinical trials.

In the context of the other options, clinical studies associated with INDs and IDEs must receive review and approval from an Institutional Review Board (IRB), ensuring that ethical considerations are prioritized. Furthermore, both INDs and IDEs typically go into effect within 30 days after submission unless the FDA communicates any concerns. This standard process is crucial for maintaining timelines in clinical research.

The inclusion of an environmental impact statement is also a requirement for certain applications. However, for INDs and IDEs specifically concerning significant-risk products, this requirement may vary and may not apply in the same way, making it the statement that could be deemed not universally true. Therefore, the necessity of an environmental impact statement or assessment, particularly a categorical exclusion, can differ based