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

• A. Class I and II devices
• B. Class I devices only
• C. Class II devices only
• D. Class II and III devices

Answer: (C)

MDUFMA created a program that lets FDA-accredited individuals conduct inspections of manufacturers for certain medical devices, specifically those that are classified as moderately risky. The idea is to expand the reach of inspection activity by trained inspectors who meet FDA standards, but only for manufacturers that meet specific qualifications.

Why this applies to moderate-risk devices is that Class II devices typically rely on more explicit quality controls and detailed premarket or postmarket data than the lowest-risk devices, yet they don’t require the same level of FDA oversight as the highest-risk Category III devices. Accrediting qualified individuals to inspect these manufacturers helps gather reliable compliance information without overburdening FDA resources, facilitating regulatory decisions like 510(k) submissions.

Low-risk Class I devices usually are governed by general controls and do not routinely need third-party inspections to support regulatory actions, so they aren’t covered by this program. High-risk Class III devices require direct FDA oversight due to safety concerns and thus remain under FDA’s own inspection regime rather than third-party inspectors.

So, the program is specifically tailored to Class II devices, allowing FDA-accredited personnel to inspect qualified manufacturers within that category.