Which section of the Code of Federal Regulations (21 CFR) covers the procedures for performance standards development?

Which section of the Code of Federal Regulations (21 CFR) covers the procedures for performance standards development?

• A. 21 CFR 861
• B. 21 CFR 830
• C. 21 CFR 814
• D. 21 CFR 812

Answer: (A)

The concept being tested is how FDA regulates the creation and updating of performance standards for medical devices. This regulatory section lays out the authority and procedures FDA uses to develop, revise, and implement performance standards, including how standards are proposed, developed with input from stakeholders, and put into effect. Knowing where this process is described helps distinguish it from parts that focus on other regulatory tasks, such as premarket submissions, labeling, or postmarket reporting. So, the section that specifically addresses the procedures for performance standards development is the one that covers how FDA creates and governs those performance standards.

The concept being tested is how FDA regulates the creation and updating of performance standards for medical devices. This regulatory section lays out the authority and procedures FDA uses to develop, revise, and implement performance standards, including how standards are proposed, developed with input from stakeholders, and put into effect. Knowing where this process is described helps distinguish it from parts that focus on other regulatory tasks, such as premarket submissions, labeling, or postmarket reporting. So, the section that specifically addresses the procedures for performance standards development is the one that covers how FDA creates and governs those performance standards.