Whole slide imaging systems used for primary diagnosis are FDA class __ medical devices.

• A. I
• B. II
• C. III
• D. IV

Answer: (B)

Understanding how the FDA handles diagnostic tools hinges on risk-based device classes. Whole slide imaging systems used for primary diagnosis are Class II devices. This means they’re considered moderate risk and require more regulatory controls than the simplest devices, but not the highest level of scrutiny. The typical clearance path is a 510(k) premarket notification, demonstrating substantial equivalence to a legally marketed predicate, along with any applicable special controls to ensure performance, reliability, and safety of the imaging during diagnosis. They’re not Class I, which covers low-risk devices often exempt from premarket review, and not Class III, which covers high-risk devices that require PMA. So Class II is the appropriate designation.