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2025 - 2026 RAC DERICE EXAM|VERIFIED
70QUESTIONS AND ANSWERS|A+GRADE
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 - ANS:->>>C 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) - ANS:->>>A Under the statutory violations, failure to meet 510(k) requirements for adevice 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 - ANS:->>>C 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 - ANS:->>>A Which of the following is exempt from GMP/QSR regulations? A. Remanufacturers B. Custom device manufacturers C. Repackagers D. Component manufacturers - ANS:->>>D 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
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. - ANS:->>>D 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 - ANS:->>>C The QSR calls for the manufacturer of finished devices to carry out all ofthe 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
- ANS:->>>B 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 - ANS:->>>B 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 - ANS:->>>A 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
B. Testing of production units under actual or simulated use conditions C. Software validation D. Translation of device design into production specifications - ANS:->>>D 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 - ANS:->>>C 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. - ANS:->>>A 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 - ANS:->>>A 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
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. - ANS:->>>B 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 - ANS:->>>A
Inspections of device components received from a supplier may frequently reveal product quality deficiencies. To avoid these instances, the supplier should first have A. Expert GMP knowledge B. Clear and precise specifications from the manufacturer C. Detailed knowledge of the manufacturer's operations D. An internal audit program - ANS:->>>B A legally marketed device to which equivalence is drawn in apremarketing submission is known as the A. Comparator device B. Predecessor device C. Predicate device D. Substantially equivalent device - ANS:->>>C A humanitarian device exemption differs from a traditional PMA in that A. It does not require compliance with QSR. B. Non-clinical data are not required. C. Effectiveness data are not required. - ANS:->>>C
B. Abbreviated 510(k) C. Traditional 510(k) D. PMA - ANS:->>>B Under the Medical Device QSR, device design requirements MUST meet the needs of the A. Manufacturer B. Patient C. User D. Patient and user - ANS:->>>D Under the IDE regulation, all of the following must be reported to the sponsor within five working days EXCEPT A. A deviation from the investigational plan B. Withdrawal of IRB approval C. An unanticipated adverse device effect D. Use of a device without informed consent - ANS:-
C Which of the following sections is required in a PMA? A. Patent certification information B. A copy of quality manual
C. An economic cost/benefit assessment D. A discussion of benefit and risk considerations - ANS:->>>D Which of the following is exempt from GMP/QSR regulations? A. Remanufacturers B. Custom device manufacturers C. Repackagers D. Component manufacturers - ANS:->>>D A medical device is refused entry to the US. All of the following may be reasons for refusal EXCEPT for the lack of A. Establishment registration by the foreign manufacturer B. Medical device listing by the foreign manufacturer C. Substantially equivalent letter from FDA D. Establishment registration by the initial distributor - ANS:->>>A Premarket Notification is required of manufacturers when introducing A. New label size B. New Class II devices C. A change in product name D. Additional manufacturing sites - ANS:->>>B All of the following are considered General Controls under the FD&C Act EXCEPT
A) Report adverse events under the Medical Device Reporting regulation B) Assisting FDA in communications with the foreign establishment, C) Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and D) Assisting FDA in scheduling inspections of the foreign establishment. - ANS:->>>A Which Congressional Act provided Statutory Authority to FDA to regulate medical devices? A) Safe Medical Devices Act of 1990 B) Medical Device User Fee and Modernization Act of 2002 C) Federal Food, Drug, Cosmetic Act D) Medical Device Amendments of 1976 - ANS:->>>D Which of the following is NOT a key Medical Device submission which directly leads to marketing permission from FDA? A) 510(k), Pre-market Notification, Part 807 B) HDE, Humanitarian Device Exemption, Part 814 C) Premarket Approval (PMA), Part 814 D) IDE, Investigational Device Exemptions, Part 812 - ANS:->>>D
At completion of review of a 510(k), FDA may take the following actions except A) Declare device substantially equivalent B) Declare device not substantially equivalent C) State a 510(k) is not required to market the device D) Approve the device for market - ANS:->>>D From a pre-clinical viewpoint, which of the following constitute pre- clinical activities in medical device development? A) Animal use testing to validate the design of your device B) Bench testing to verify that your design performs as designed C) Biocompatibility/Toxicity testing D) Functional/Safety/Performance testing E) All of the above - ANS:->>>E
C) Supply the applicable sections of the finished device manufacturer's PMA directly to FDA D) Include a certification in the finished device manufacturer's PMA that the proprietary information meets FDA's requirements - ANS:->>>A Under the official definition of a "device", all of the following are considered devices except A) X-ray film B) Sterilizers used for device manufacturing C) Eyeglass lenses and frames D) In vitro diagnostic kit - ANS:->>>B 510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluation except A) High Flux Hemodialyzer B) Blood specimen collection device C) Piston syringe D) Cardiopulmonary bypass blood tubing - ANS:->>>B The Quality System Regulation (QSR) for medical devices (21CFR 820) pertains to the manufacturing of which of the following
A) Finished devices, but not accessories B) Finished devices and components of finished devices C) Finished devices and accessories to finished devices D) Finished devices, components, and accessories to finished devices - √Answer C The QSR for Class III devices applies to the following except A) Critical component manufacturers B) Operations done by the manufacturer at facilities located in the United States C) Research on investigational devices tested outside of the United States D) Contract Sterilizers - ANS:->>>A The QSR for medical devices (21CFR 820) requires all of the following except A) Management to make a commitment to quality B) A Quality Plan that defines how quality will be met C) Management must review the Quality System at least quarterly D) A Quality representative must be identified and documented - ANS:->>>C The QSR for medical devices regarding Design Controls require which ofthe following
