Which statement is NOT true regarding INDs and IDEs for significant-risk products?

When considering the regulatory framework for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs) pertaining to significant-risk products, an essential aspect is compliance with current Good Manufacturing Practice (cGMP) regulations. While it is true that clinical studies for drugs and devices must adhere to quality and safety standards, it is not correct to say that investigational products must strictly comply with cGMP at the outset of their testing. Rather, cGMP compliance is often required for the manufacture of the final product intended for market, but investigational products can be used in clinical trials under different standards that allow for flexibility during the development phase.

In contrast, other statements about INDs and IDEs are indeed accurate. The requirement for clinical studies to be approved by an Institutional Review Board (IRB) ensures the protection of human subjects involved in research. Furthermore, an IND or IDE does not automatically become effective upon submission; it can go into effect typically 30 days after the FDA receives the application unless the FDA raises concerns. Additionally, for significant-risk products, an environmental impact statement is necessary to address potential effects on the environment, thereby ensuring comprehensive regulatory oversight.

Thus, the statement regarding the requirement for investigational products to comply