US RAC Exam Prep 2026 Study Guide

US RAC Exam Prep Study Guide

29. CFR: Code of Federal Regulations 30. Class I Device: Low-risk device requiring general controls to ensure safety and effectiveness. 31. Class II Device: Requires general and special controls to ensure safety and effectiveness. Special controls may include mandatory performance standards, patient registries for implantable devices and postmarket surveillance. Requires 510(k), unless exempted; may require clinical trials. 32. Class III Device: Requires general controls, special controls and premarket approval (PMA); includes devices that are lifesustaining, life-supporting or pose significant potential for risk to patient, or are not substantially equivalent to Class I or Class II devices. PMAs almost always require clinical trials. 33. Clearance: Devices that receive marketing permission through the 510(k) process based on demonstrating substantial equivalence to a pre-amendment de- vice or another device reviewed under section 510(k) of the FD&C Act. 34. Clinical Hold: FDA order to delay proposed clinical investigation or suspend an ongoing investigation. 35. Combination Product: Defined in 21 CFR 3.2(e) as a combination of two or more different types of regulated products, i.e.: - a drug and a device - a device and a biological product - a drug and a biological product - a drug, a device and a biological product 36. Commercial Distribution: Any distribution of a device intended for human use, which is offered for sale but does not include: internal or interplant transfer within the same parent, subsidiary or affiliate company any device with an approved exemption for investigational use. 37. Common Rule: Requires the research institution's IRB to ensure that each research protocol contains adequate provisions to protect a subject during the course of the study. 38. Complaint: Any written, electronic or oral communication alleging deficiencies related to a product's identity, quality, durability, reliability, safety, effectiveness or performance after release for distribution. 39. Component: Any ingredient or part intended for use in the manufacture of a drug, device, cosmetic, biologic or IVD product, including those that may not appear in the finished product. 40. Cosmetic: Articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering appearance; and, arti- cles intended for use as a component of any such article; except that such term shall not include soap.