RAC Devices Practice Exam 2023/2024 with Complete Solutions

A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is the manufacturer preparing to submit to FDA? 0 A PMA 1 A Special 510(k), 2 An Individual Device Exemption (IDE), 3 An Annual Report for a PMA - ANSWER-A Special 510(k) A company wishes to expand existing labeling for a medical device to include a new indication for use. What action should the regulatory professional take FIRST? - ANSWER-Contact the review division to determine whether a 510(k) or PMA should be prepared. A company is submitting a PMA for a permanent implant. The company has performed biocompatibility testing based on ISO requirements and believes the package is complete. Which of the following testing does the company absolutely need to demonstrate long-term safety of its device: 0 Intracutaneous irritation, 1 Genotoxicity, 2 Acute toxicity, 3 Carcinogenicity - ANSWER-Carcinogenicity If a device fails to comply with any paragraph of the QSR is it adulterated? - ANSWER-Yes What source should the regulatory professional consult to determine when a product's patent and exclusivity will expire? 0 FederalRegister 1 TheOrange Book, 2 Patentand Trademark Office, 3 CopyrightOffice - ANSWER-The orange book An FDA reviewer contacts a regulatory professional with a lengthy list of questions regarding a submitted 510(k) application. Some of the information is not readily available and may require additional data collection. What is the BEST course of action for the regulatory professional? - ANSWER-Send a letter with anticipated response time. An IVD submission could be submitted as a(n): A. NDA