RAC bestmaxsolutions 1 RAC Practice Exam 2023-2024 U pdate Questions With Complete Solutions A Special 510(k) must contain all of the following components EXCEPT: A. Proposed Labeling B. Design Controls Activity Summary C. 510(k) Summary or 510(k) Statement D. Summary of Safety and Effectiveness Data [Ans: - D. Summary of Safety and Effectiveness Data Summary of Safety and Effectiveness Data is not a requirement of a Special 510(k). Sec. 807.87 Information required in a premarket notification submission. (j) For submissions claiming substantial equivalence to a device which has been classified in to class III under section 513(b) of the act: (1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990; and (2) For which no final regulation requiring premarket approval has been i ssued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III summary). The 510(k) submitte r shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (class III certification), as described in 807.94. This information does not refer to information that already has been submitted to the Food and Drug Administration (FDA) under section 519 of the act. FDA may require the submission of the adverse safety and effectiveness data described in the class III summary or citation. A company is developing a demineralized bone matrix (DBM) product intended as a bone void filler. The DBM product consists of DBM manufactured from human allograft bone and a polymer gel to improve handling and containment of the DBM in the bone defect. The DBM product must comply with the following regulation(s): A. 21 CFR 210 and 211 B. 21 CFR 820 C. 21 CFR 1271 D. 21 CFR 1271 and 820 [Ans: - D. 21 CFR 1271 and 820 RAC bestmaxsolutions 2 Demineralized bone matrix alone (i.e., not combined with another component) is an HCT/P wh ich meets the four criteria to be regulated solely under Section 361 of the Public Health Service Act. FDA, however, has determined the addition of certain components to DBM, such as polymer gels or calcium phosphates, meets the definition of a device as t hey are intended to affect the structure or function of the body by assisting in the filling of bone voids. These DBM products, therefore, are regulated as devices by CDRH (510(k) clearance required) and as such must comply with 21 CFR 820 Quality System R egulation. In addition, the product also needs to comply with the requirements of 21 CFR 1271 Human Cells, Tissues and Cellular and Tissue -Based Products due to the human tissue component. You work for a company that is developing an autologous cellular t herapy product. FDA informed your company that its product will be regulated as an HCT/P (Human Cells, Tissues and Cellular and Tissue -Based Product). Based on this information, with which of the following regulatory requirements will your company need to be compliant when manufacturing the product? A. 21 CFR (CGMP requirements for pharmaceuticals) B. 21 CFR 2171 and 21 CFR 820 C. All Subparts of 21 CFR 1271 except Subpart C (Donor Eligibility) D. All Subparts of 21 CFR 1271 [Ans: - C. All Subparts of 21 CFR 1271 except Subpart C (Donor Eligibility) As the product is regulated under section 361 of the PHS Act, it is only subject to the requirements in 21 CFR 1271, with the exception of Subpart C , as autologous products are not subject to donor eligibility requirements. A drug manufacturer is assembling a clinical evaluation plan for a New Chemical Entity (NCE) to include in an IND submission. Which of the following NCE studies DOES NOT need to b e included by the manufacturer in the clinical trial registry at www.clinicaltrials.gov? A. Phase 1 studies B. Phase 2 studies C. Phase 3 studies D. Phase 4 postmarketing studies [Ans: - A. Phase 1 studies Clinical Trials That Must be Registered at Clin icalTrials.gov —FDAAA, Title VIII, Sec. 801 ("Applicable Clinical Trials") RAC bestmaxsolutions 3 —Trials of drugs and biologics: controlled clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation —Trials of devices: (a) a prospective cl inical study of health outcomes comparing an intervention with a device, subject to FDA regulation, against a control in human subjects, (other than small feasibility studies), and (b) pediatric postmarket surveillance The two mechanisms to amend an OTC M onograph are: A. Time & Extent Application (TEA) or Annual Report B. Time & Extent Application (TEA) or Citizen Petition C. Annual Report or Preapproval Supplement D. Citizen Petition or Preapproval Supplement [Ans: - B. Time & Extent Application (TEA) o r Citizen Petition Which of the following is NOT required in a Biologics License Application (BLA) but is required in a New Drug Application (NDA)? A. FDA form 3397 (user fee cover sheet) B. Field copy certification C. Chemistry section D. Debarment cert ification [Ans: - B. Field copy certification Field copy certification only applies to NDA products, whereas all of the others sections are requirements for both BLAs and NDAs. Your company would like to submit an IND for the use of a new drug on subjects with a life -
threatening disease for which the re are no suitable alternative drugs available. Which type of IND application would be most suitable for this type of investigation? A. Treatment IND B. Emergency Use IND C. Investigator IND D. Expanded access IND [Ans: - A. Treatment IND RAC bestmaxsolutions 4 A treatment IN D would be most suitable for this application (answer 1). Treatment INDs are issued as a means of providing eligible subjects with investigational drugs or biologics for the treatment of serious and life -threatening illnesses for which there are no suitabl e alternative treatments. You are assigned the task of obtaining an Orphan Drug Designation (ODD) for a novel investigational drug for new onset Type I diabetes mellitus. Which of the following is NOT among your points of consideration for this ODD applic ation? A. The ODD application must be submitted for review to FDA Office of Orphan Products Development (OOPD) B. This investigational drug may qualify for ODD as new onset Type I diabetes mellitus may be a medically plausible disease subset under the Orp han Drug Act C. The ODD application must be submitted electronically to the OOPD through the FDA Electronic Submission Gateway (ESG) D. The scientific rationale and population prevalence are two areas of the ODD application that are most critically reviewe d by FDA [Ans: - C. The ODD application must be submitted electronically to the OOPD through the FDA Electronic Submission Gateway (ESG) Sponsors may send the submission directly to OOPD on physical media with a signed paper cover letter. How many days d oes FDA have to review an Abbreviated 510(k)? A. 30 days B. 60 days C. 90 days D. 180 days [Ans: - C. 90 days Because both Special 510(k) and Abbreviated 510(k) are alternate approaches to the Traditional 510(k), with the goal of streamlining evaluation of the application, the Special 510(k) review clock is 30 days. Many people often think the review clock for an Abbreviated 510(k) is also 30 days, but it is actually 90. Which federal law made it illegal for physicians being reimbursed by federally funded programs to prescribe or recommend that the patient use a particular manufacturer's medical products when the doctor receives payment from that manufacturer?
threatening disease for which the re are no suitable alternative drugs available. Which type of IND application would be most suitable for this type of investigation? A. Treatment IND B. Emergency Use IND C. Investigator IND D. Expanded access IND [Ans: - A. Treatment IND RAC bestmaxsolutions 4 A treatment IN D would be most suitable for this application (answer 1). Treatment INDs are issued as a means of providing eligible subjects with investigational drugs or biologics for the treatment of serious and life -threatening illnesses for which there are no suitabl e alternative treatments. You are assigned the task of obtaining an Orphan Drug Designation (ODD) for a novel investigational drug for new onset Type I diabetes mellitus. Which of the following is NOT among your points of consideration for this ODD applic ation? A. The ODD application must be submitted for review to FDA Office of Orphan Products Development (OOPD) B. This investigational drug may qualify for ODD as new onset Type I diabetes mellitus may be a medically plausible disease subset under the Orp han Drug Act C. The ODD application must be submitted electronically to the OOPD through the FDA Electronic Submission Gateway (ESG) D. The scientific rationale and population prevalence are two areas of the ODD application that are most critically reviewe d by FDA [Ans: - C. The ODD application must be submitted electronically to the OOPD through the FDA Electronic Submission Gateway (ESG) Sponsors may send the submission directly to OOPD on physical media with a signed paper cover letter. How many days d oes FDA have to review an Abbreviated 510(k)? A. 30 days B. 60 days C. 90 days D. 180 days [Ans: - C. 90 days Because both Special 510(k) and Abbreviated 510(k) are alternate approaches to the Traditional 510(k), with the goal of streamlining evaluation of the application, the Special 510(k) review clock is 30 days. Many people often think the review clock for an Abbreviated 510(k) is also 30 days, but it is actually 90. Which federal law made it illegal for physicians being reimbursed by federally funded programs to prescribe or recommend that the patient use a particular manufacturer's medical products when the doctor receives payment from that manufacturer?
