What does 21 CFR parts 1-100 address?

The correct answer is that 21 CFR parts 1-100 primarily address Administrative Issues and Protection of Human Subjects. This regulation is part of the Code of Federal Regulations that outlines the responsibilities and requirements for various aspects of regulatory compliance and oversight in the United States.

Specifically, these parts establish the general administrative procedures for the Food and Drug Administration (FDA), including the agency's operational framework, the enforcement of laws, and various protections in the context of research involving human subjects. The sections within this range also discuss the essential protocols and principles required to ensure the ethical treatment of individuals participating in clinical trials, as mandated by regulations governing human subject protection.

This is crucial for maintaining public trust and ethical standards in research and clinical practices. Regulatory compliance in medical research not only safeguards subjects’ rights and welfare but also contributes to the integrity of the data collected, which ultimately influences public health and safety decisions.

By focusing on administrative issues and human subject protection, this regulatory part lays the groundwork for the safe and effective development of medical products while ensuring compliance with ethical standards.