23-33.pdf

A. True B. False Answer: B Question: 73 FDA order to delay proposed clinical investigation or suspend an ongoing investigation. A. True B. False Answer: B Question: 74 Devices that receive marketing permission through the 510(k) process based on demonstrating substantial equivalence to a pre-amendme...

A. True B. False Answer: B Question: 73 FDA order to delay proposed clinical investigation or suspend an ongoing investigation. A. True B. False Answer: B Question: 74 Devices that receive marketing permission through the 510(k) process based on demonstrating substantial equivalence to a pre-amendment device or another device reviewed under section 510(k) of the FD&C Act. A. True B. False Answer: A Question: 75 Investigational New Drug Application (IND) A. True B. False Answer: A Question: 76 The study of the process of ADME (Absorption, Distribution, Metabolism and Excretion) of chemicals and medicines. (aka what the body does to the drug) A. True Visit us at B. False Answer: B Question: 77 Violative device would cause serious serious adverse health consequences. A. True B. False Answer: A Question: 78 Orphan Drugs A. True B. False Answer: B Question: 79 Drugs intended to threat life-threatening and severely debilitating illnesses A. True B. False Answer: A Question: 80 Bioresearch Monitoring Program A. True B. False Answer: B Visit us at Question: 81 Fees authorized by Congress to fund various FDA activities. The fee schedule for different application types is published annually in the Federal Register. Initially established by PDUFA and later extended to medical devices, generic drugs and animal drugs. A. True B. False Answer: B Question: 82 Biologics A. 21 cfr 207 B. 21 Cfr parts 590s C. 21 CFR parts 600s D. 42 Cfr parts 600s Answer: C Question: 83 Electronic Common Technical Document A. transitional device B. eCTD C. common rule D. orphan drug Answer: B Question: 84 Any display of written, printed or graphic matter on the immediate container or package of, or affixed to, any article. A. Sticker Visit us at B. Label C. Component D. Ppe Answer: B Question: 85 Premarket Approval of Medical Devices A. 21 Cfr 807 B. 21 Cfr 312 C. 21 CFR 814 D. 21 Cfr 207 Answer: C Question: 86 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution A. 21 Cfr 312 B. 21 Cfr 1035 C. 21 CFR 207 D. 21 Cfr 202 Answer: C Question: 87 section 515 that requires a minor change to a device, such as a minor change to the design of the device, software, sterilization or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement. A. Modular Pma B. Suitability Petition C. Shelf Life D. Real Time PMA Supplement Answer: D Visit us at Question: 88 Request for Designation. A written submission to OCP requesting designation of the center with primary jurisdiction for a combination or non-combination product. A. ROA B. INREM C. DFD D. RFD Answer: D Question: 89 The Food and Drug Administration Amendments Act of 2007. Reauthorized a number of key programs, including PDUFA, MDUFMA and PRE A. FDAAA requires all clinical trials of drugs, biologics and devices - except phase I clinical trials - to be registered in a clinical trial databank. ClinicalTrials.gov, established by the National Institute of Health (NIH)/National Library of Medicine (NLM) in collaboration with FDA, meets FDAAA mandates. FDAAA permits FDA to require sponsors to submit direct-to-consumer (DTC) television advertisements for agency review no later than 45 days before dissemination of the advertisement and permits FDA to impose penalties of as much as $500,000 for false and misleading DTC advertisements. A. DESI B. HIPAA C. FDAAA D. MEDWATCH Answer: C Question: 90 Absorption, Distribution, Metabolism and Excretion A. DMR B. RF VALUE C. ADME D. ACME Answer: C Visit us at Question: 91 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 Answer: D Question: 92 Which of the following is true regarding ICH guidelines? A. ICH guidelines represent the joint opinions of regulatory agencies in US, Europe and Japan. B. ICH guidelines represent the joint opinions of the pharmaceutical industry and regulatory agencies in US, Europe and Japan. C. ICH guidelines represent the joint opinions of the pharmaceutical industry in US, Europe and Japan. D. ICH guidelines represent the joint opinions of the pharmaceutical industry and regulatory agencies in US, Europe, Canada and Japan Answer: B Question: 93 Who has final authority over content of an Informed Consent? A. FDA B. Sponsor C. Investigator D. IRB Answer: D Question: 94 According to the QSR, Personnel involved in the design, manufacture, distribution, servicing, and reporting must: Visit us at A. Be trained in their area of responsibility B. At a minimum receive procedure training once per year in their area of responsibility C. Be able to recite the Quality Policy, if asked D. Be made aware of defects which may occur if they do not perform their job correctly Answer: D Question: 95 A sponsor must report an unexpected, fatal or life-threatening experience believed to be associated with an unapproved drug/biologic: A. to FDA, investigators and IRBs within 7 calendar days B. to FDA and investigators within 7 calendar days C. to FDA within 14 calendar days D. to FDA and investigators within 7 working days Answer: A Question: 96 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 Answer: E Question: 97 Which of the following is not found in the Orange Book? A. Patent information for approved drug products B. Exclusivity information for approved drug products C. Information related to therapeutic equivalence for approved drug products D. Drugs on the market approved only on the basis of safety or pre-1938 drugs Visit us at Answer: D Question: 98 If FDA were to invoke the Application Integrity Policy, which of the following is a possible outcome? A. Defer review of pending application(s) B. "File" a marketing application at the 60 day review C. Grant a waiver or deferral for pediatric clinical study D. Approve a marketing application Answer: A Question: 99 Which of the following medical device types are not subject to Manufacturer tracking: A. Life-sustaining or life-supporting device used outside of a device-user facility B. Life-sustaining or life-supporting device used inside of a device-user facility C. Permanently implantable device D. Devices sold to a distributor for ultimate delivery (sale) to end-user Answer: B Question: 100 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 Answer: D Question: 101 510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluation except: Visit us at A. High Flux Hemodialyzer B. Blood specimen collection device C. Piston syringe D. Cardiopulmonary bypass blood tubing Answer: B Question: 102 As a regulatory affairs professional, you are responsible for developing the content of an information package for a Type B meeting with FD A. Your primary objective is to: A. Reach consensus on content from contributing team members B. Ensure content is sufficient to support meeting objective(s) and questions to FDA C. Provide appropriate preclinical summary D. Provide appropriate clinical summary Answer: B Question: 103 Informed consent documentation must be compliant with all except the following: A. Signature of the subject or the subject's legal representative B. Revised due to new information regarding the investigational product that might affect a subject's willingness to participate in the study becomes available C. Approved by the clinical trial site IRB D. Revised due to change in contact person name and/or phone number Answer: D Question: 104 Which of the following is not an example of misbranding? A. An incorrect lot number on the label B. A drug product without a manufacturer, packer or distributor on the label C. Font size of established name is 25% of the font size of the trade name D. Lack of NDC on label Visit us at Answer: D Question: 105 You are developing a combination product and believe the primary mode of action will designate the product as a drug as opposed to a device. Your first course of action is to: A. Develop written rationale describing the product, mode(s) of action, and proposed classification as a drug B. Submit a formal request for designation to the Office of Combination Products C. Call the CDER review division D. Check the FDA website for information, eg, other combination/similar products Answer: D Question: 106 Which of the following devices would be regulated by CBER? A. Warming device B. Blood pressure cuff C. HIV diagnostic test kit D. Capillary blood collection tube Answer: C Question: 107 Which of the following statements regarding Establishment Registration is correct? A. Since my medical device is manufactured by a contract manufacturer, our facility is not required to register. B. As a contract sterilizer, my facility does not need to register. C. As a foreign establishment, my firm is required to register. D. The Establishment Registration fee is waived for small companies Answer: C Question: 108 Visit us at The establishment, performance and auditing of a human-use clinical device trial requires conformance with all of the following except: A. 21 CFR 50 Protection of Human Subjects B. 21 CFR 56 IRB C. 21 CFR 807 Establishment Registration D. 21 CFR 812 IDE Exemptions Answer: C Question: 109 Clinical protocol amendments are required for the following except: A. Increase in drug dosage or duration of subject exposure B. Addition of a new clinical investigator C. Significant change in protocol design D. Phase 1 study design changes that do not affect critical safety assessments. Answer: D Question: 110 Which of the following is a covered study as defined under Financial Disclosure regulations: A. Phase I dose escalation study B. Phase I/II Pharmacokinetic Study C. A large open label safety study conducted at a large number of study sites D. Phase III pivotal study Answer: D Question: 111 The following are characteristics of FDA GMP inspections except: A. Results of internal audit findings are required to be provided to the FDA Inspectors upon request B. Biennial inspections of manufacturing facilities take place to verify compliance with regulations. C. The FDA may inspect the drug product sponsor and any manufacturing subcontractors. D. FDA inspections may be conducted due to serious non-compliance with GMP regulations Visit us at