MDUFMA allows FDA-accredited individuals to inspect qualified manufacturers of which class of devices?

Medical Device User Fee and Modernization Act (MDUFMA) establishes a framework in which certain qualified individuals accredited by the FDA are given authority to conduct inspections of manufacturers. This is particularly relevant for Class II and Class III devices.

Class II devices are typically subject to more stringent regulatory controls than Class I devices due to their higher risk potential. Therefore, they require a more thorough inspection process to ensure compliance with safety and effectiveness standards. Class III devices, being the highest risk category, often necessitate premarket approval and extensive oversight. MDUFMA facilitates the inspection of these manufacturers, ensuring that the compliance and quality standards are adequately met.

Class I devices, generally low-risk and subject to the least regulatory control, usually do not require such rigorous inspection protocols. As a result, FDA-accredited individuals do not inspect manufacturers of Class I devices under the provisions set by MDUFMA. This is why the correct answer pertains specifically to Class II and III devices, aligning with the regulations that focus on higher-risk medical devices requiring comprehensive manufacturing oversight.