Questions and Answers PDF

Answer: A Question: 152 In Vitro Diagnostic A. True B. False Answer: D Question: 153 Prohibited the interstate commerce and transport of adulterated and misbranded food and drugs under penalty of seizure of questionable product and/or prosecution of responsible parties. A. True B. False Answer: A Qu...

Answer: A Question: 152 In Vitro Diagnostic A. True B. False Answer: D Question: 153 Prohibited the interstate commerce and transport of adulterated and misbranded food and drugs under penalty of seizure of questionable product and/or prosecution of responsible parties. A. True B. False Answer: A Question: 154 Unexpected Adverse Device Effect. Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem or death was not previously identified in nature, severity or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety or welfare or subjects. A. True B. False Answer: A Question: 155 The absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. Visit us at A. True B. False Answer: A Question: 156 A finished dosage form (e.g., tablet, capsule, solution, etc.) that contains an active drug ingredient. It is generally, but not necessarily, also associated with inactive ingredients. This includes a finished dosage form that does not contain an active ingredient but is intended to be used a as placebo. A. True B. False Answer: A Question: 157 Office of Combination Products (FDA) A. True B. False Answer: B Question: 158 Under the BPCI Act (Biologics Price Competition and Innovation Act of 2009), a biological product may be demonstrated to be "biosimilar" if data show that, among other things, the product is "highly similar" to an already approved biological product. A. True B. False Answer: B Question: 159 Device History Record. Contains a device's production history. Visit us at A. True B. False Answer: B Question: 160 21 CFR 316. The act guarantees the developer of an orphan product seven years of market exclusivity following FDA's approval of the product. Incentives also include tax credits for clinical research undertaken by a sponsor to generate data required for marketing approval. A. True B. False Answer: A Question: 161 Which of the following is typically included in a reminder advertisement? A. Brand and generic names B. Indication(s) C. Dose information D. Statement of efficacy Answer: A Question: 162 When an FDA inspector arrives at a facility, he or she must present is A. Form FDA 482 and credentials B. EIR C. Form FDA 483 and Notice of Inspection D. Form FDA 484 Answer: A Question: 163 Visit us at Which of the following convey "intended use" for a drug product? A. Prescribing information B. Verbal statements by sponsor or sponsor's representative about a product's use at a trade show C. Printed promotional materials D. All of the above Answer: D Question: 164 Which Congressional Act provided Statutory Authority to FDA to regulate medical devices? A. Safe Medical Devices Act of 1990 (SMDA) B. Medical Device User Fee and Modernization Act of 2002 (MDUFMA) C. Federal Food, Drug, Cosmetic Act (FDC Act) D. Medical Device Amendments of 1976 (MDA) Answer: D Question: 165 Design Control "verification" requires which of the following: A. The product design meets the users needs B. The process produces a product that meets predetermined specifications C. The product design meets specified requirements D. The product design meets the intended use requirements Answer: D Question: 166 An liquid-filled teething ring (for use by infants) is an example of what type of device? A. Class 1 B. Class 2 C. Class 3 D. Not a device Visit us at Answer: B Question: 167 Dental floss is an example of what kind of device? A. Class 1 B. Class 2 C. Class 3 D. Not a device Answer: A Question: 168 In the clinical development plan for an investigational antihypertensive drug, which of the following studies would typically be conducted first: A. 1 month repeat dose toxicology study B. Single dose escalation PK study in healthy volunteers C. Multiple dose PK study in healthy volunteers D. Single dose escalation study in hypertensive patients Answer: B Question: 169 For a medical Device, what is NOT a responsibility of the US Agent for a Foreign Establishment? 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. Answer: A Question: 170 Visit us at Which of the following statements regarding foreign establishments wishing to market medical devices in the U.S. is incorrect? A. Foreign manufacturers must designate a U.S. Agent B. Foreign establishments must register in the U.S. C. Foreign manufacturers must list all medical devices imported to the U.S. D. Foreign manufacturers cannot sponsor a 510(k) premarket notification for a medical device Answer: D Question: 171 Institutional Review Boards are responsible for conducting which of the following activities: A. Training of clinical research staff B. Reporting subject SAEs to the sponsor C. Giving informed consent to subjects D. Review and approval of clinical protocols Answer: D Question: 172 You have just been hired as Director of Regulatory Affairs at a contract sterilizer from a similar position at a surgical instrument manufacturer and are reviewing your firms' records. You haven't come across any device listing forms for the devices your firm sterilizes that are commercially available in the U.S. Which of the following responses is correct? A. Contact FDA to request a large number of Device Listing forms and assign a member of your staff to begin completing a form for each device your firm sterilizes. B. Exclude devices from foreign manufacturers from the list being prepared above. C. Find something else to worry about, contract sterilizers are not required to submit Device Listing forms for the devices they manufacture. Answer: C Question: 173 As a regulatory affairs professional, you are provided evidence that your firm's product has been the subject of criminal tampering post-distribution which has resulted in 2 known deaths. You assemble the appropriate internal team in order to implement a Visit us at A. Class I Recall B. Class II Recall C. Class III Recall D. Market Withdrawal Answer: D Question: 174 An acupuncture needle is an example of what kind of device? A. Class 1 B. Class 2 C. Class 3 D. Not a device Answer: B Question: 175 According to the QSR, Document Controls apply to: A. Design History File (DHF) B. Device Master Record (DMR) C. Device History Record (DHR) D. All of the above Answer: D Question: 176 For a marketed product, which of the following is an example of a "Changes Being Effected-30 days" supplement? A. Deletion or reduction of an ingredient to affect color B. New analytical method C. Addition of an alternate analytical method D. Change in site of testing from one facility to another Answer: D Visit us at