RAC Devices Practice Exam Questions with 100% Correct Answers | Latest Version 2024 | Verified

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 - 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? - 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 - Carcinogenicity