RAC Practice Exam 1 Questi ons and Answers New Version 2024 Complete 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 dele te electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic records. D Establishment of and adherence to written procedures - Answer ✔️✔️-A. The final authority for ensuring the adequacy of an Investigational New Drug (IND) informed consent document resides with the: - Answer ✔️✔️-Institutional Review Board (IRB) A sponsor wishes to obtain permission from FDA to submit an ANDA for a drug product that varies from the Reference Listed Drug (RLD) in route of administration, dosage form, or strength, but anticipates that the labeling will be identical to that of the RLD. What process should be used to apply for that permission from FDA? - Answer ✔️✔️-Suitabi lity Petition A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to market a - Answer ✔️✔️-New chemical entity when the sponsor has a right of reference to all applicable published studies Distribution records for drug products must reference or contain: - Answer ✔️✔️-Name and address of the consignee A mid -sized pharmaceutical company negotiated with FDA to submit a draft Package Insert (PI) and patient medication guide (MedGuide) in annota ted Word format for initial FDA review, and committed to submit the Labeling in Structured Product Label (SPL) format upon approval of their product. What is the preferred timeline for this pharmaceutical company to submit the SPL formatted labeling upon p roduct approval? - Answer ✔️✔️-14 days Adverse event reporting for a marketed biologics product is NOT required for: - Answer ✔️✔️-
Diagnostic non -invasive test kits The quality assurance manager of a small company consisting of 12 employees is the only internal auditor for the company and has been performing all internal quality system audits for three years. This does not meet the requirements for performing internal quality systems audits because - Answer ✔️✔️-Auditor independence has not been ensured. You have modified your 510(k) -cleared device with a Special 510(k). In which case would a Special 510(k) not be appropriate for the device? - Answer ✔️✔️-You have changed the primary mechanism of action. Which Premarket Approval Application (PMA) supplements are NOT subject to user fee exemption? - Answer ✔️✔️-Real Time Supplement A medical device company allows its sales force to maintain a product inventory in the field. The device has an expiration date indicated on its labeling. A sales person notes that one of his products has expired and contacts the headquarters office for direction. He is told to return the product to the headquarter office for replacement. The return of this product is considered as what type of recall? - Answer ✔️✔️-Not a recall —it is considered normal stock rotation A company is developing an (unapproved) drug -device combination product but is not sure to which center it should submit its marketing application. The company should first submit - Answer ✔️✔️-A Request for Designation t o the Office of Combination Products A medical device company is developing a product with drug, biologic and device components. The product and indication have not been previously classified by FDA. What is the most appropriate regulatory pathway? - Answe r ✔️✔️-A Request for Designation (RFD) should be sent to the Office of Combination Products (OCP) at FDA to determine the primary mode of action (PMOA) and assign the agency with primary jurisdiction. FDA's Office of Generic Drugs (OGD) remains committed t o the "first -in, first -reviewed" review order for the reviewing original Abbreviated New Drug Applications (ANDAs), amendments and supplements unless there is a specific reason to expedite an application. What is NOT a specific reason to grant expedited re view? - Answer ✔️✔️-Products that show evidence of safety and effectiveness in a new subpopulation A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test, a microhematocrit analyzer that, among other intended uses, can determine the hematocrit of a blood donor prior to donation of a blood product. The firm should address the 510(k) submission to: - Answer ✔️✔️-CBER Notice of Intent to Revoke license can be issued for the following reason, EXCEPT A Unable to gain access t o the manufacturing plant, B Licensed product are no longer safe and effective C Failure to report serious adverse event, D Manufacturer fails to conform to applicable standards - Answer ✔️✔️-C What is the formal early collaboration meeting that was imple mented through the Food and Drug Modernization Act (FDAMA)? - Answer ✔️✔️-Agreement Meeting The Agreement Meeting is a formal meeting to agree upon the parameters of the investigational plan. When a meeting request is received by FDA, the meeting will be h eld within 30 days. The agreements made at the meeting are provided in writing to the sponsor and are binding on FDA. Regulatory Reference: Early Collaboration Meetings Under the FDA Modernization Act; Final Guidance for Industry and for CDRH Staff (Februa ry 2001).
Diagnostic non -invasive test kits The quality assurance manager of a small company consisting of 12 employees is the only internal auditor for the company and has been performing all internal quality system audits for three years. This does not meet the requirements for performing internal quality systems audits because - Answer ✔️✔️-Auditor independence has not been ensured. You have modified your 510(k) -cleared device with a Special 510(k). In which case would a Special 510(k) not be appropriate for the device? - Answer ✔️✔️-You have changed the primary mechanism of action. Which Premarket Approval Application (PMA) supplements are NOT subject to user fee exemption? - Answer ✔️✔️-Real Time Supplement A medical device company allows its sales force to maintain a product inventory in the field. The device has an expiration date indicated on its labeling. A sales person notes that one of his products has expired and contacts the headquarters office for direction. He is told to return the product to the headquarter office for replacement. The return of this product is considered as what type of recall? - Answer ✔️✔️-Not a recall —it is considered normal stock rotation A company is developing an (unapproved) drug -device combination product but is not sure to which center it should submit its marketing application. The company should first submit - Answer ✔️✔️-A Request for Designation t o the Office of Combination Products A medical device company is developing a product with drug, biologic and device components. The product and indication have not been previously classified by FDA. What is the most appropriate regulatory pathway? - Answe r ✔️✔️-A Request for Designation (RFD) should be sent to the Office of Combination Products (OCP) at FDA to determine the primary mode of action (PMOA) and assign the agency with primary jurisdiction. FDA's Office of Generic Drugs (OGD) remains committed t o the "first -in, first -reviewed" review order for the reviewing original Abbreviated New Drug Applications (ANDAs), amendments and supplements unless there is a specific reason to expedite an application. What is NOT a specific reason to grant expedited re view? - Answer ✔️✔️-Products that show evidence of safety and effectiveness in a new subpopulation A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test, a microhematocrit analyzer that, among other intended uses, can determine the hematocrit of a blood donor prior to donation of a blood product. The firm should address the 510(k) submission to: - Answer ✔️✔️-CBER Notice of Intent to Revoke license can be issued for the following reason, EXCEPT A Unable to gain access t o the manufacturing plant, B Licensed product are no longer safe and effective C Failure to report serious adverse event, D Manufacturer fails to conform to applicable standards - Answer ✔️✔️-C What is the formal early collaboration meeting that was imple mented through the Food and Drug Modernization Act (FDAMA)? - Answer ✔️✔️-Agreement Meeting The Agreement Meeting is a formal meeting to agree upon the parameters of the investigational plan. When a meeting request is received by FDA, the meeting will be h eld within 30 days. The agreements made at the meeting are provided in writing to the sponsor and are binding on FDA. Regulatory Reference: Early Collaboration Meetings Under the FDA Modernization Act; Final Guidance for Industry and for CDRH Staff (Februa ry 2001).
