RAC BUNDLED Exams 2023/2024 with 100% correct answers

[Q]Which meeting is held with the FDA for the purpose of reaching concurrence on the key parameters of the investigational plan for a Class III device? [A] Agreement meeting [B] Determination meeting [C] Presubmission meeting [D] PMA Day-100 meeting - correct answer [A] Agreement meeting [Q...

Which of the following is considered part of the Device Master Record? A. Employee training record B. Labeling specifications C. Design reviews D. Calibration records - correct answer B. Labeling specifications Question Feedback: Labeling specifications are part of the DMR A company ...

You work for a German-based device manufacturer (Company A) that produces a power supply based on a US-based medical device company's (Company B) design. The power supply is imported into your company's US-based manufacturing site (Company C) for further processing and then sent to the US-based me...

Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of sys...

Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - correct answer C. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The anti...

Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - correct answer A: Proof of efficacy Which amendments to the...

Administrative Procedure Act - correct answer federal law enacted in 1946, "notice and comment rulemaking" 1906: The Pure Food and Drug Act (PFDA) - correct answer interstate commerce labeling 1912 Pure Food and Drug Act - correct answer revised in 1912, stated that a drug was misbran...

Facility Registration - Devices - within XX days of application or manufacturing - correct answer 30 days Facility Re-Registration - Devices, Drugs & Biologics - correct answer Annual GLP & GCP Record Retention - correct answer 5 Years - from application or 2 Years - from approval or t...

Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug. 505 (B) 1 &2 - correct answer 21 CFR 314.54 WHAT CAN'T BE SUBMITTED AS 505(B)(2) APPLICATIONS? - correct answer · An application that is a duplicate...

drug - correct answer Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. medical device - correct answer An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar or relate article, including any co...

(EU) MA - correct answer Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA - correct answer National, centralised, mutual recognition, decentralized procedures MAH - correct answer A legal perso...

A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days. B. 15 calendar days. C. ...

Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - correct answer C A company wants to modify its legally marketed device such that the modification does not affect the intended use or alt...