2024 RAC Medical Marketing Practice Exam With Answers (89 Solved Questions)

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RAC Practice Exam Latest Updated 2024 With Complete SolutionsYou have modified your 510(k)-cleared device with a Special 510(k). In which casewould a Special 510(k) not be appropriate for the device? - You have changed theprimary mechanism of action.Which Premarket Approval Application (PMA) supplements are NOT subject to userfee exemption? - Real Time SupplementA medical device company allows its sales force to maintain a product inventory inthe field. The device has an expiration date indicated on its labeling. A sales personnotes that one of his products has expired and contacts the headquarters officefor direction. He is told to return the product to the headquarter office forreplacement. The return of this product is considered as what type of recall? -Not a recall—it is considered normal stock rotationA company is developing an (unapproved) drug-device combination product but isnot sure to which center it should submit its marketing application. The companyshould first submit - A Request for Designation to the Office of CombinationProductsA medical device company is developing a product with drug, biologic and devicecomponents. The product and indication have not been previously classified byFDA. What is the most appropriate regulatory pathway? - A Request forDesignation (RFD) should be sent to the Office of Combination Products (OCP) atFDA to determine the primary mode of action (PMOA) and assign the agency withprimary jurisdiction.

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FDA's Office of Generic Drugs (OGD) remains committed to the "first-in, first-reviewed" review order for the reviewing original Abbreviated New DrugApplications (ANDAs), amendments and supplements unless there is a specificreason to expedite an application. What is NOT a specific reason to grantexpedited review? - Products that show evidence of safety and effectiveness in anew subpopulationA firm is preparing a 510(k), premarket notification to FDA for an in vitrodiagnostic test, a microhematocrit analyzer that, among other intended uses, candetermine the hematocrit of a blood donor prior to donation of a blood product.The firm should address the 510(k) submission to: - CBERNotice of Intent to Revoke license can be issued for the following reason, EXCEPTA Unable to gain access to the manufacturing plant,B Licensed product are no longer safe and effectiveC Failure to report serious adverse event,D Manufacturer fails to conform to applicable standards - CWhat is the formal early collaboration meeting that was implemented through theFood and Drug Modernization Act (FDAMA)? - Agreement MeetingThe Agreement Meeting is a formal meeting to agree upon the parameters of theinvestigational plan. When a meetingrequest is received by FDA, the meeting will be held within 30 days. Theagreements made at the meeting are provided in writing to the sponsor and arebinding on FDA. Regulatory Reference: Early Collaboration Meetings Under the FDAModernization Act; Final Guidance for Industry and for CDRH Staff (February 2001).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 ofoperator entries and actions that create, modify or delete electronic records.

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B Validation of systems to ensure accuracyC Authority checks to ensure that only authorized personell can create, modify ordelete electronic records.D Establishment of and adherence to written procedures - A.The final authority for ensuring the adequacy of an Investigational New Drug (IND)informed consent document resides with the: - Institutional Review Board (IRB)A sponsor wishes to obtain permission from FDA to submit an ANDA for a drugproduct that varies from the Reference Listed Drug (RLD) in route ofadministration, dosage form, or strength, but anticipates that the labeling will beidentical to that of the RLD. What process should be used to apply for thatpermission from FDA? - Suitability PetitionA 505(b)(2) NDA is not an appropriate regulatory submission for the approval tomarket a - New chemical entity when the sponsor has a right of reference to allapplicable published studiesDistribution records for drug products must reference or contain: - Name andaddress of the consigneeA mid-sized pharmaceutical company negotiated with FDA to submit a draftPackage Insert (PI) and patient medication guide (MedGuide) in annotated Wordformat for initial FDA review, and committed to submit the Labeling in StructuredProduct Label(SPL) format upon approval of their product. What is the preferred timeline forthis pharmaceutical company to submit the SPL formatted labeling upon productapproval? - 14 days

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Adverse event reporting for a marketed biologics product is NOT required for: -Diagnostic non-invasive test kitsThe quality assurance manager of a small company consisting of 12 employees isthe only internal auditor for the company and has been performing all internalquality system audits for three years. This does not meet the requirements forperforming internal quality systems audits because - Auditor independence hasnot been ensured.A US medical device contract manufacturer has customers for whom itmanufactures medical device components (parts) and finished medical devices. Todate, all products have been either parts for Class II medical devices or Class IIfinished medical devices. The manager of new business contacts the regulatorymanager to assess the impact of a possible new customerinvolving a Class III device. What is the first question the regulatory managershould ask in order to begin assessing the impact of Class III on plant operations?- Is it a component or device that would be manufactured?The following biological products are regulated by CBER EXCEPT:A Immunizing toxoids,B Monoclonal antibodies for in vitro use,C Monoclonal antibodies for in vivo use,D Infusion of animal sourced cells into a hum - BYou work for a company that is developing an autologous cellular therapy product.FDA has informed your company that your product will be regulated as a HCT/P(Human Cells, Tissues and Cellular and Tissue-Based Product). Based on thisinformation, which of the following regulatory requirements will your companyneed to be compliant with when manufacturingthe product? - All Subparts of 21 CFR 1271 except Subpart C (Donor Eligibility)

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A company has submitted its NDA for review. An NDA amendment can besubmitted to change or add information to a not yet-approved NDA. When must new safety information be submitted in a safety updatereport? - Four months after the initial NDA submission (120 day safety update)A television advertisement that you have been asked to review prior to releasediscusses the benefits of the drug in detail for 25 seconds, and then names all themajor side effects associated with the product in the last five seconds. You shouldadvise that: - The benefits and side effects of the drug should be presented withthe same level of scope, depth and detail.At the completion of a Preapproval Inspection where a deficiency was noted, ameeting is convened to discuss what document? - Form FDA 483Due to market interest, a new strength for an existing combination OTC productfor use in the adult population (labeled as 12 years of age and older) has beendeveloped, and appropriate data have been gathered to support safety andefficacy. The existing product is regulated by a final monograph, but does notcontain labeling for use of the new strength in adult populations. What optionscould the company utilize to modify the monograph in order to gain FDA approvalto market the new dosing regimen? - New Drug Application; Citizen's Petition; andTime and Extent ApplicationIf a company is planning to market a medical device that is substantiallyequivalent to a device marketed before 1976, it can use which regulatory path? -510(k)

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If a device failure is occurring with greater than expected frequency andinvestigation of the problem indicates improper use by the end user, which of thefollowing should occurs?A The labeling is revised,B The product is recalled,C The product is redesigned,D A Dear Doctor letter is issued - The labeling is revisedAn Investigational New Drug Application (IND) goes to "Inactive Status" when: - Nosubjects are entered into clinical trials for a period of two years or IND is onclinical hold for one year.Financial disclosure is required for investigators who, during the time the clinicalinvestigator is carrying out the study and for one year following the completion ofthe study, have: - Been a prior employee of the sponsor company and own stockworth more than $50,000 (US)An Investigational New Drug Application (IND) was submitted to FDA. New animaltoxicology data is obtained and will be submitted to FDA as: - As an informationamendment submitted no more than every 30 days.Your company is planning to market an allergen patch test. Which center shouldoversee the approval process? - CBERFDA is authorized to regulate advertising for what type(s) of medical devices? -Restricted devicesYour company wishes to seek approval of a combination of individually approvedanti-hypertensive and anti-diabetic drugs.

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