12-22.pdf

Question: 34 Low-risk device requiring general controls to ensure safety and effectiveness. A. Class I Device B. Phase Iv C. Class Iii Recall D. Banned Device Answer: A Question: 35 Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. A. Cosmeti...

Question: 34 Low-risk device requiring general controls to ensure safety and effectiveness. A. Class I Device B. Phase Iv C. Class Iii Recall D. Banned Device Answer: A Question: 35 Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. A. Cosmetic B. Expiration Date C. Drug D. Biologic Answer: C Question: 36 Substantially Equivalent. A. 21 CFR 50 B. SE C. CDER D. IND Answer: B Question: 37 Common Technical Document for drug submissions across US, EU and Japan. Now the eCTD (electronic Common Technical Document) to the FD A. Developed by the ICH (International Conference of Harmonization). Divided into 5 modules. Visit us at Module 1 - Regional Admin Information (US, EU, or Japan) Module 2 - Summaries/Overviews of Modules 3-5 Module 3 - Quality Module 4 - Non-Clinical Study Reports Module 5 - Clinical Study Reports A. ANDA B. CTD C. RFD D. eCTD Answer: B Question: 38 Official communication from FDA informing an NDA or BLA sponsor of an agency decision; includes approvable, not approvable and clinical hold. A. Complaint B. Action Letter C. Phase Iv D. Pre-sub Meeting Answer: B Question: 39 The complete PMA application is submitted to FDA at once. This method is generally used if the device has already undergone clinical testing and has been approved in a country with established medical device regulations. A. Modular Pma B. Product Development Protocol (pdp) C. Humanitarian Device Exemption D. Traditional PMA Answer: D Question: 40 Product containing any filthy, putrid or decomposed substance; or prepared under unsanitary conditions; or not made according to GMPs; or containing an unsafe color additive; or does not meet the requirements of an official compendium (FD&C Act, SEC. 501 ) Visit us at A. Misbranded B. Grandfathered C. Adulterated D. Adulteration Answer: C Question: 41 Tacit approval for drugs marketed before 1938 and devices marketed before May 1976. A. Misbranded B. Approved C. Grandfathered D. Adulterated Answer: C Question: 42 Federal Food, Drug and Cosmetics Act (FD&C Act) is a law enacted by Congress. The 1938 FD&C Act replaced the Pure Food & Drug Act and revise the misbranding standard for therapeutic claims in a way that helped further differentiate food labeling from drug labeling. The 1938 law tightened the standard from "false and fraudulent" to "false and misleading in any particular." The 1938 Act also introduced premarket drug review, requiring the manufacturer of a "new drug" (defined as a drug not generally recognized as safe) to submit a New Drug Application (NDA) to FDA, setting forth the company's evidence of the drug's safety. A. Kefauver-harris Amendment of 1962 B. FD&C Act of 1938 C. Durham-humphrey Amendment of 1951 D. Fd&c Act of 1943 Answer: B Question: 43 A pilot program in the Division of Clinical Laboratory Devices. A complete PMA is submitted as in a traditional PMA; however, the Streamlined PMA is for a device in which the technology and use are well known to the FDA. Visit us at A. Streamlined PMA B. Shelf Life C. Expiration Date D. Modular Pma Answer: A Question: 44 Medical Device User Fee and Modernization Act. Established fees for Premarket Approval applications (PMAs), supplements and 510(k) submissions. In return, FDA committed to strict performance goals for medical technology reviews. A. MDUFMA of 2002 B. Mdufma of 1992 C. Mdufma of 2001 D. Mdufma of 1902 Answer: A Question: 45 Scheduled within 60 days of FDA receipt of a written meeting request. Type B meetings are as follows: - Pre-investigational new drug application (pre-IND) meetings (21 CFR 312.82) - Certain end-of-phase 1 meetings (21 CFR 312.82) - End-of-phase 2 and pre-phase 3 meetings (21 CFR 312.47) - Pre-new drug application/biologics license application meetings (21 CFR 312.47) A. Type B Meeting B. Pre-Sub Meeting C. Bioequivalence D. Drug Product Answer: A Question: 46 Changes Being Effected in 30 days. A submission to an approved application reporting changes the FDA has identified as having moderate potential to adversely affect drug product identity, strength, quality, purity and potency. The supplement must be received by FDA at least 30 days before product distribution. Visit us at A. Cbe-35 B. CBE-30 C. Cbe-70 D. Cbe-20 Answer: B Question: 47 Device presenting a substantial deception, unreasonable risk or injury or illness, or unreasonable direct substantial danger to public health. A. Banned Device B. Market Withdrawl C. Class Iii Device D. Transitional Device Answer: A Question: 48 Refuse to File. Letter sent by FDA when incomplete NDA or ANDA is filed. FDA will not review the application until complete. Letter is sent within 60 days of submission. A. RTF B. TIF C. PDF D. TXT Answer: A Question: 49 The clinical evaluation of a device an the development of necessary information for marketing approval are merged into one regulatory mechanism. Ideal candidates fort he PDP process are those devices in which they technology is well established. A. Target Product Profile (tpp) B. De novo process C. Clinical hold D. Product Development Process (PDP) Visit us at Answer: D Question: 50 A request to FDA to submit an ANDA for a product that varies from a Reference Listed Drug in indication, strength, dosage form, route of administration, etc. A. Citizen Petition B. Notice Of Opportunity For Hearing C. Commercial Distribution D. Suitability Petition Answer: D Question: 51 Document used to inform a potential subject of the risks and benefits of a clinical trial per the Declaration of Helsinki. A. Primary Mode of action (pmoa) B. Common rule C. Ind D. Consent Form (CF or ICF) Answer: D Question: 52 Provides a route to market for medical devices that are low to moderate risk, but that have been classified in Class III because FDA has found them to be "not substantially equivalent" (NSE) to legally marketed predicate devices. A. True B. False Answer: A Question: 53 Visit us at Studies and clinical trials that sponsors are required to conduct under one or more statutes or regulations. A. True B. False Answer: B Question: 54 The single mode of action of a combination product that provides the most important therapeutic action of the combination product that provides the most important therapeutic action of the combination product; used to assign a combination product to a lead FDA center. A. True B. False Answer: B Question: 55 Division of Medication Error Prevention and Analysis (CBER) A. True B. False Answer: A Question: 56 Firm-initiated removal or correction of a device, drug or biologic product involving a minor violation of the FD&C Act, not subject to legal action by FDA, or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. A. True B. False Answer: A Question: 57 Visit us at Device Master File. Analagous to a drug master file; submission to FDA that may be used to provide confidential detailed information about a medical device or a component used in the manufacture of a medical device to FDA in support of another party's obligation. A. True B. False Answer: A Question: 58 A type of 510(k) submission that is supported by conformance with guidance document(s), special controls or standards. FDA processing time is 90 days. A. True B. False Answer: B Question: 59 Medical Device User Fees Amendments represented a commitment between US medical device industry and FDA to increase the efficiency of regulatory process in order to reduce the time it takes to bring safe and effective medical device to the US market. Reauthorized by FDASIA. A. True B. False Answer: A Question: 60 Ethical principles for medical research involving human subjects. Trials conducted under Good Clinical Practice generally follow the Declaration of Helsinki. A. True B. False Answer: A Visit us at Question: 61 Code of Federal Regulations A. True B. False Answer: B Question: 62 Biologics License Application A. True B. False Answer: A Question: 63 Investigation Device Expemptions A. True B. False Answer: A Question: 64 Allows a company to file the completed portions of an NDA for an ongoing review by FD A. Only permitted for drugs and biologics that have received Fast Track designation from FDA. A. True B. False Answer: A Question: 65 Visit us at FDA review category for drugs that appear or represent an advance over available therapy. NDA or BLA receives a faster review than standard applications. A. True B. False Answer: A Question: 66 Postmarket clinical trials performed to support labeling and advertising to fulfill FDA safety requirements noted at the time of NDA approval. A. True B. False Answer: A Question: 67 Protection of Human Subjects A. True B. False Answer: B Question: 68 Center for Devices and Radiological Health A. True B. False Answer: A Question: 69 Visit us at Communicates FDA's decision to a drug company that its new drug application (NDA) or abbreviation new drug application (ANDA) to market a new or generic drug will not be approved in its present form. A. True B. False Answer: A Question: 70 Three types of protocols related to PDUFA products are eligible for this special protocol assessment under the PDUFA goals: (1) animal carcinogenicity protocols, (2) final product stability protocols, and (3) clinical protocols for phase 3 trials whose data will form the primary basis for an efficacy claim if the trials had been the subject of discussion at an end-of-phase 2/pre-phase 3 meeting with the review division, or in some cases, if the division agrees to such a review because the division is aware of the developmental context in which the protocol is being reviewed and the questions are being answered. The clinical protocols for phase 3 trials can relate to efficacy claims that will be part of an original new drug application (NDA) or biologics license application (BLA) or that will be part of an efficacy supplement to an approved NDA or BLA. A. True B. False Answer: A Question: 71 Requires manufacturers to assess the safety and effectiveness of certain drug and biological products in pediatric patients. A. True B. False Answer: A Question: 72 Articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering appearance; and, articles intended for use as a component of any such article; except that such term shall not include soap. Visit us at