Rac Exam Practice Exam Questions With Answers

True or False: A device modification always requires either a 510(k) or a PMA filing.(18:3) {Ans: False}An independent peer-reviewed journal article on an off-label use of an approved biologic may be disseminated. How many days prior to dissemination should the information be submitted to FDA? e) 0 days f) 30 days g) 60 days h) 3 months(24:3) {Ans: g) 60 days}RUO and IUO products a) cannot be marketed with diagnostic claims b) are subject to QSR requirements c) are considered safe and effective for IVD use(21:5) {Ans: a) cannot be marketed with diagnostic claims}If the company in question 1 (14:1) decides to submit a 505(b)(2) application containing only comparative bioequivalence/bioavailability information would that applicant qualify for a period of three-year exclusivity?(14:2) {Ans: No. In order for a company to qualify for three-year exclusivity the sponsor must submit "reports of new clinical investigations (other than bioavailability studies) " that are "essential to approval" of the application and that are "conducted or sponsored by" the applicant.}Select the requirements for submission of promotional labeling to FDA that are TRUE: a) All promotional labeling must be submitted to FDA at the time of initial publication or dissemination. b) The form