RAC Practice Exam 2026-2027 Update Questions With Complete Solutions (74pages)

A Special 510(k) must contain all of the following components EXCEPT: A. Proposed Labeling B. Design Controls Activity Summary C. 510(k) Summary or 510(k) Statement D. Summary of Safety and Effectiveness Data [Ans: - D. Summary of Safety and Effectiveness Data Summary of Safety and Effectiveness Data is not a requirement of a Special 510(k). Sec. 807.87 Information required in a premarket notification submission. (j) For submissions claiming substantial equivalence to a device which has been classified into class III under section 513(b) of the act: (1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990; and (2) For which no final regulation requiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III summary). The 510(k) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (class III certification), as described in 807.94. This information does not refer to information that already has been submitted to the Food and Drug Administration (FDA) under section 519 of the act. FDA may require the submission of the adverse safety and effectiveness data described in the class III summary or citation. A company is developing a demineralized bone matrix (DBM) product intended as a bone void filler. The DBM product consists of DBM manufactured from human allograft bone and a polymer gel to improve handling and containment of the DBM in the bone defect. The DBM product must comply with the following regulation(s): A. 21 CFR 210 and 211 B. 21 CFR 820 C. 21 CFR 1271 D. 21 CFR 1271 and 820 [Ans: - D. 21 CFR 1271 and 820