2024 DEVICE Clinical Analysis RAC Exam With Answers (187 Solved Questions)

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DEVICE RAC EXAM2024|Questionswith 100%Correct Answers | Verified | Latest Update 2024|Graded A+Which division would have primary jurisdiction over a vascular graft with anantibiotic based on primary mode of action?A. CDERB. CBERC. CDRHD. OCP-✔✔CA company wants to modify its legally marketed device such that the modificationdoes not affect the intended use or alter the fundamental scientific technology ofthe device. If the design outputs of the modified device meet the design inputrequirements,this change would be best filed as a(n):A. Special 510(k)B. Abbreviated 510(k)C. Traditional 510(k)

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D. De novo 510(k)-✔✔AUnder the statutory violations, failure to meet 510(k) requirements for a devicethat is required to have a 510(k) and is in commercial distribution is considered tobe:A. Adulteration.B. Improper useC. MisbrandedD. Fraudulent-✔✔CA company's competitor is marketing a Class II suture which dissolves during thethird week of use. The company's current product has to be removed by aphysician. However, a change in weaving configuration gives this product thesame dissolving time as the competitor's. When can the company's new suture bemarketed?

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A. This requires a new 510(k) since significant change in product instructionsmightaffect efficacy.B. After submission in a periodic reportC. After reporting clinical studies in an annual reportD. After submission of labeling change-✔✔AWhich of the following is exempt from GMP/QSR regulations?A. RemanufacturersB. Custom device manufacturersC. RepackagersD. Component manufacturers-✔✔DA physician reports to a manufacturer that a patient was hospitalized with acutesepsis after treatment with an approved device. This side effect is not listed in the

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package insert. This event must be reported by the manufacturer to FDA no laterthan:A. 5 calendar daysB. 15 calendar daysC. 30 calendar daysD. The next quarterly or annual report-✔✔CIf a device failure is occurring with greater than expected frequency andinvestigation of the problem implicates improper use by the end user, which ofthe following typically occurs?A. The labeling is revised.B. The product is recalled.C. The product is redesigned.D. A "Dear Doctor" letter is issued.-✔✔AA handling andstorage system for medical devices must always include:

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A. Procedures for rotation of stockB. Separate rooms or cages for release and quarantine productsC. Procedures for receipt and transfer of productD. Environmentally controlled areas for products with shelf life-✔✔CYou have modified your 510(k) cleared device with a special 510(k). In which ofthe following cases would you need to create a new listing for the device?A. You have added new sizes and shapes in the product portfolio.B. You have changed the material composition of the device.C. You have changed the package of the device.D. None of the above.-✔✔DAccording to the QSR, when an investigation of a complaint is conducted all of thefollowing are requirements for inclusion in the record of the investigation EXCEPT:A. The dates and results of the investigationB. The nature and details of the complaint

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C. Changes in procedures correcting quality problemsD. Any reply to the complainant-✔✔CThe QSR calls for the manufacturer of finished devices to carry out all of thefollowing EXCEPT:A. Conduct quality audits by individuals who do not have direct responsibility forthe operation being auditedB. Audit operations annuallyC. Document the dates and results of quality audits and re-auditsD. Have findings reviewed by management responsible for the matters audited-✔✔BWhich of the following subsystems is NOT required by FDA in order to implementand maintain a Quality System?A. Production and process controlsB. Test and control article characterization

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C. Packaging and labeling controlsD. Facility and equipment controls-✔✔BAccording to the Quality System Regulations, re-testing and re-evaluation ofnonconforming devices after rework activities must be documented in the:A. Device history recordB. Device master recordC. Quality manualD. Design history file-✔✔AWhich of the following manufacturers must register their manufacturing facilitywith FDA?A. Component manufacturers who sell only to the device manufacturer usingtheircomponents

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B. Domestic (US) contract manufacturers who follow another person'sspecifications anddo not commercially distribute the devices to the marketC. Domestic manufacturer of device being investigated under an IDED. Foreign manufacturers shipping devices into the US for sale in the US.-✔✔DUnder 21 CFR 812, the IDE regulation, which of the following statements is FALSE?A. An investigator shall report to the sponsor within 5 working days a withdrawalof approval by the IRB.B. The investigator shall report device use without obtaining informed consent tothe sponsor and the reviewing IRB within 10 working days after the use occurs.C. The sponsor shall notify FDA within 30 working days of the completion ortermination of an investigation for a significant risk device.D. An investigator shall submit to the sponsor and IRB a report of anyunanticipated

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adverse device effectwithin 10 working days after the investigator first learns oftheeffect.-✔✔BWhen design validation activities are being performed by a manufacturer, whichelement is NOT included as a requirement under device design validation sectionof the QSR?A.Conformance to defined user needs and intended usesB. Testing of production units under actual or simulated use conditionsC. Software validationD. Translation of device design into production specifications-✔✔DA manufacturer of which of the following must file an IDE before conducting ahuman clinical study?A. A device in commercial distribution before 28 May 1976 when used orinvestigated in

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accordance with its indications in labeling in effect at that timeB. A device intended solely for veterinary useC. A custom device being studied for safety and effectiveness in support ofcommercialmarketingD. A device in commercial distribution before 28 May 1976 when used orinvestigated inaccordance with its indications in labeling in effect at that timeand intendedsolely forveterinary use-✔✔CWhich one of the following statements is NOT true with respect to both INDs andIDEs for significant-risk products?A. The investigational product must be manufactured in full compliance withcGMP.B. Clinical studies must be reviewed and approved by an Institutional ReviewBoard.

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C. The IND or IDE goes into effect 30 days after FDA receives the application,unlessFDA notifies the sponsor otherwise.D. The application must include an environmental impact statement that containsa claimfor categorical exclusion or an environmental assessment.-✔✔AThe initial importer of a medical device MUST:A. Report incidents in which a device may have caused or contributed to a deathor serious injuryB. Maintain quality assurance filesC. Share responsibility for submittals with other distributorsD. Report device malfunctions in an annual report-✔✔A

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During a monitoring visit, the sponsor discovers that an investigator had used adevice in a clinical investigation without obtaining informed consent from thesubject. Which of the following should the regulatory affairs professional do?A. Predate the informed consent with a memo to the site fileB. Contact the patient to obtain the informed consent immediatelyC. Ensure that the study director for the sponsor discusses the issue with theinvestigatorD. Report the protocol deviation to the IRB-✔✔CThe regulatory affairs professional should perform all of the following prior tosubmitting a PMA to FDA EXCEPT:A. Prepare criteria for the MDR reportB. Prepare a brief statement of reasons for noncompliance with regulationC. Identify all omissions in PMA contentD. Review, organize and check adequacy of data pertaining to safety and efficacyevaluation-✔✔A

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All Class I medical devices are subject to the following requirements EXCEPT:A. Device Master File (DMF)B. Design History File (DHF)C. Device History Record (DHR)D. Medical Device Reporting (MDR)-✔✔BMDUFMA authorizes FDA-accredited persons to inspect qualified manufacturersof:A. Class I and II devicesB. Class I devices onlyC. Class II devices onlyD. Class II and III device-✔✔D

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MDUFMA authorized 3rd party establishment inspections under carefullyprescribed conditions. All the following prescribed conditions about 3rd partyestablishment inspections are true EXCEPT:A. The establishment must market at least one device in the US and must marketa device"in one or more foreign countries."B. Manufactures of class III devices are not eligible for 3rd party inspections.C. In order to be eligible, an establishment's most recent inspection must be NAIor VAI.D. Establishments are required to notify FDA of the person it intends to use andFDAmust agree to the selection.-✔✔BFDA has sent a warning letter citing mislabeling of a small manufacturer'sartificial knee device. The regulatory affairs professional should first contact the:A. Compliance Branch in their district

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B. Orthopedic Branch Chiefin the CDRH Office of Device EvaluationC. Division of Small Manufacturers, International and Consumer Assistance(DSMICA)in CDRH.D. CDRH Ombudsman-✔✔AInspections of device components received from a supplier may frequently revealproduct quality deficiencies. To avoid these instances, the supplier should firsthave:A. Expert GMP knowledgeB. Clear and precise specifications from the manufacturerC. Detailed knowledge of the manufacturer's operationsD. An internal audit program-✔✔B

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