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Question No 1: A physician reports to a manufacturer that a patient was hospitalized with acute seps is after treatment with an approved device. This side effect is not listed in the package insert. This even t 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. Answer: C
Question No 2: 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.
Answer: C
Question No 3: When design verification testing is being performed by a manufacturer, which eleme nt is NOT included as a potential requirement under device design verification section of the QSR? A. Identification of the design B. Software validation C. Identification of test methods used. D. Name of individuals performing the testing .
Answer: C
Question No 4: Under the statutory violations, lack of an approved PMA for a PMA device that is not exempt and is in commercial distribution is considered to be: A. Adulteration. B. Improper use. C. Misbranded. D. Fraudulent.
Answer: A
Question No 5: A manufacturer 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 investigate d 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. D. A device in commercial distribution before 28 May 1976 when used or investigate d in accordance with its indications in labeling in effect at that time. And a device int ended solely for veterinary use. Answer: C
Question No 6: The regulatory affairs professional performs all of the following prior to submitting a PMA to FDA EXCEPT: A Preparing criteria for the MDR report. B. Preparing a brief statement of reasons for noncompliance with regulation. C. Identifying all omissions in PMA content. D. Reviewing, organizing and checking adequacy of data pertaining to safety and effi cacy evaluation. Answer: A
Question No 7: 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. Answer: D
Question No 8: Subacute toxicity testing should be performed: A. In two rodent species. B. In one rodent and one non-rodent species. C. For a minimum of two weeks. D. For a minimum of six months. Answer: B
Question No 9: What FDA clearances are required to export a drug approved by FDA? A. Certificate of Free Sale. B. Customs Tax Stamps. C. No clearance required. D. FDA receipt for sample Form-484. Answer: C
Question No 10: Fully quality-assured individual toxicology reports are not required for submission of an initial IND application. However, finalized and fully quality assured reports should be available to FDA upon request within what period of the start of the human study ?
A 90 days. B. 120 days. C. One year. D. The final report is only required in the submission for the NDA Answer: B
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