100+ Free RAC (Devices) Practice Questions

Explanation: The FDA classifies devices into three classes (I, II, III) based on the level of control necessary to provide reasonable assurance of safety and effectiveness, with risk increasing from Class I to Class III. Class III is the highest-risk tier and generally requires premarket approval.

Explanation: A 510(k) demonstrates substantial equivalence (SE) to a legally marketed predicate device in terms of intended use and technological characteristics. It is a notification, not an approval, and does not generally require independent proof of safety and effectiveness through pivotal trials.

Explanation: Premarket Approval (PMA) is the most stringent device marketing application and is generally required for Class III devices that support or sustain life. A PMA requires valid scientific evidence, typically including clinical data, to establish reasonable assurance of safety and effectiveness.

Explanation: The De Novo pathway provides a route to market for novel devices of low to moderate risk for which there is no legally marketed predicate, allowing classification into Class I or II. A granted De Novo can then serve as a predicate for future 510(k) submissions.

Explanation: An IDE allows an investigational device to be used in a clinical study in order to collect the safety and effectiveness data needed to support a marketing application. It is governed by 21 CFR Part 812 and is not itself a marketing authorization.

Explanation: Effective February 2, 2026, the revised 21 CFR Part 820 (the QMSR) incorporates ISO 13485:2016 by reference, harmonizing FDA quality system requirements with the international standard for medical device quality management systems. FDA-specific provisions remain in Part 820 where ISO 13485 was not fully sufficient.

Explanation: Under 21 CFR Part 803, manufacturers must submit an MDR to FDA no later than 30 calendar days after becoming aware of information reasonably suggesting that a device may have caused or contributed to a death or serious injury, or has malfunctioned in a way likely to do so if it recurred.

Explanation: A UDI consists of a device identifier (DI), a mandatory fixed portion identifying the labeler and device version/model, and a production identifier (PI), a conditional variable portion that may include lot/batch, serial number, expiration date, or manufacture date.

Explanation: A Class I recall is the most serious category and involves a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II involves temporary or medically reversible consequences, and Class III is unlikely to cause adverse health consequences.

Explanation: Under 21 CFR 806, a correction is the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal to another location. A removal, by contrast, involves the physical relocation of the device.