DEVICE RAC EXAM - Questions and Answers (Complete Solutions)

DEVICE RAC EXAM - Questions and Answers (Complete Solutions) 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 A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this change would be best filed as a(n): A. Special 510(k) B. Abbreviated 510(k) C. Traditional 510(k) D. De novo 510(k) Under the statutory violations, failure to meet 510(k) requirements for a device that is required to have a 510(k) and is in commercial distribution is considered to be: A. Adulteration. B. Improper use C. Misbranded D. Fraudulent A company's competitor is marketing a Class II suture which dissolves during the third week of use. The company's current product has to be removed by a physician. However, a change in weaving configuration gives this product the same dissolving time as the competitor's. When can the company's new suture be marketed? A. This requires a new 510(k) since significant change in product instructions might affect efficacy. B. After submission in a periodic report C. After reporting clinical studies in an annual report D. After submission of labeling change Which of the following is exempt from GMP/QSR regulations? A. Remanufacturers B. Custom device manufacturers C. Repackagers D. Component manufacturers 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. 30 calendar days D. The next quarterly or annual report If a device failure is occurring with greater than expected frequency and investigation of the problem implicates improper use by the end user, which of the 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. A handling and storage system for medical devices must always include: A. Procedures for rotation of stock B. Separate rooms or cages for release and quarantine products C. Procedures for receipt and transfer of product D. Environmentally controlled areas for products with shelf life You have modified your 510(k) cleared device with a special 510(k). In which of the 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. According to the QSR, when an investigation of a complaint is conducted all of the following are requirements for inclusion in the record of the investigation EXCEPT: A. The dates and results of the investigation B. The nature and details of the complaint C. Changes in procedures correcting quality problems D. Any reply to the complainant The QSR calls for the manufacturer of finished devices to carry out all of the following EXCEPT: A. Conduct quality audits by individuals who do not have direct responsibility for the operation being audited B. Audit operations annually C. Document the dates and results of quality audits and re-audits D. Have findings reviewed by management responsible for the matters audited Which of the following subsystems is NOT required by FDA in order to implement and maintain a Quality System? A. Production and process controls B. Test and control article characterization C. Packaging and labeling controls D. Facility and equipment controls According to the Quality System Regulations, re-testing and re-evaluation of nonconforming devices after rework activities must be documented in the: A. Device history record B. Device master record C. Quality manual D. Design history file Which of the following manufacturers must register their manufacturing facility with FDA? A. Component manufacturers who sell only to the device manufacturer using their components B. Domestic (US) contract manufacturers who follow another person's specifications and do not commercially distribute the devices to the market C. Domestic manufacturer of device being investigated under an IDE D. Foreign manufacturers shipping devices into the US for sale in the US. Under 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 withdrawal of approval by the IRB. B. The investigator shall report device use without obtaining informed consent to the 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 or termination of an investigation for a significant risk device. D. An investigator shall submit to the sponsor and IRB a report of any unanticipated adverse device effect within 10 working days after the investigator first learns of the effect. When design validation activities are being performed by a manufacturer, which element is NOT included as a requirement under device design validation section of the QSR? A. Conformance to defined user needs and intended uses B. Testing of production units under actual or simulated use conditions C. Software validation D. Translation of device design into production specifications A manufacturer which of the following must file an IDE before conducting a human clinical study? A. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time B. A device intended solely for veterinary use C. A custom device being studied for safety and effectiveness in support of commercial marketing D. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time and intended solely for veterinary use Which one of the following statements is NOT true with respect to both INDs and IDEs for significant-risk products? A. The investigational product must be manufactured in full compliance with cGMP. B. Clinical studies must be reviewed and approved by an Institutional Review Board. C. The IND or IDE goes into effect 30 days after FDA receives the application, unless FDA notifies the sponsor otherwise. D. The application must include an environmental impact statement that contains a claim for categorical exclusion or an environmental assessment. The initial importer of a medical device MUST: A. Report incidents in which a device may have caused or contributed to a death or serious injury B. Maintain quality assurance files C. Share responsibility for submittals with other distributors D. Report device malfunctions in an annual report During a monitoring visit, the sponsor discovers that an investigator had used a device in a clinical investigation without obtaining informed consent from the subject. Which of the following should the regulatory affairs professional do? A. Predate the informed consent with a memo to the site file B. Contact the patient to obtain the informed consent immediately C. Ensure that the study director for the sponsor discusses the issue with the investigator D. Report the protocol deviation to the IRB The regulatory affairs professional should perform all of the following prior to submitting a PMA to FDA EXCEPT: A. Prepare criteria for the MDR report B. Prepare a brief statement of reasons for noncompliance with regulation C. Identify all omissions in PMA content D. Review, organize and check adequacy of data pertaining to safety and efficacy evaluation 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) MDUFMA authorizes FDA-accredited persons to inspect qualified manufacturers of: A. Class I and II devices B. Class I devices only C. Class II devices only D. Class II and III device MDUFMA authorized 3rd party establishment inspections under carefully prescribed conditions. All the following prescribed conditions about 3rd party establishment inspections are true EXCEPT: A. The establishment must market at least one device in the US and must market a 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 NAI or VAI. D. Establishments are required to notify FDA of the person it intends to use and FDA must agree to the selection. FDA has sent a warning letter citing mislabeling of a small manufacturer's artificial knee device. The regulatory affairs professional should first contact the: A. Compliance Branch in their district B. Orthopedic Branch Chief in the CDRH Office of Device Evaluation C. Division of Small Manufacturers, International and Consumer Assistance (DSMICA) in CDRH. D. CDRH Ombudsman