RAC Sample Test Questions with 100% Correct Answers | Latest Version 2024 | Verified

Which of the following is considered part of the Device Master Record? A. Employee training record B. Labeling specifications C. Design reviews D. Calibration records - B. Labeling specifications Question Feedback: Labeling specifications are part of the DMR A company has a new oral drug, GOODDRUG, it wishes to market in the US. Studies on intravenous GOODDRUG have been conducted by several academic centers demonstrating safety and efficacy and have been published in peer-reviewed journals. The most-appropriate method to gain approval would be by filing a: A. ANDA B. SNDA C. 505(b)2 D. 505(b)1 - C. 505(b)2 Question Feedback: Since the drug has been studied and those results published, a comparability study between IV and oral dosage forms is acceptable under a 505(b)2 Your company is considering a new drug product. It has been on the market for more than 30 years in a foreign country, but has never been approved in the US. To sell this product in the US, you may do the following immediately EXCEPT: A. Determine monograph or NDA status of the product B. Initiate clinical studies in the foreign country to support the claims since the clinical data are old and would not meet current requirementsC. Determine whether this is a New Chemical Entity D. Import the product and use new labeling - D. Import the product and use new labeling Question Feedback: The importation of a drug product to be distributed in the US must meet US regulations, regardless of its approved status in another country, therefore answer 4 is correct. A company is developing a combination product consisting of a device that injects a specially formulated small molecule drug for pain into the muscle tissue. Which of the following describes the best US regulatory path: A. The product is regulated as a drug B. The product is regulated under CDRH C. The company should file a BLA to obtain US marketing approval D. The company should submit a request for designation to OCP - A. The product is regulated as a drug Question Feedback: Primary mode of action is the pain drug and the device is a delivery system FDA has issued a Complete Response Letter to a company. The company views many of the deficiencies as minor. The regulatory professional should meet with the team to: A. Devise a strategy for responding to all deficiencies identified by FDA B. Devise a strategy to respond to any minor deficiencies in order to restart the review clock C. Inform the team a Class 1 resubmission has a six-month review clock D. Inform the team a Class 2 resubmission has a three-month review clock - A. Devise a strategy for responding to all deficiencies identified by FDA Question Feedback: Resubmissions purport to answer all of the deficiencies needing to be addressed by the applicant prior to the original application's approval as set forth in a previous action letter. A drug manufacturer creates a game-based simulation to assist diabetes patients with management of their blood glucose levels and to motivate them to adhere to their medication schedules. The game will be based on a password protected website that will be made available to patients when an FDAapproved drug is prescribed to them. How will the game most likely be regulated by FDA?A. It should be included as part of the NDA submission B. It will be regulated as a Class I medical device C. It will be regulated as an in vitro diagnostic product D. It will not be an FDA regulated product - D. It will not be an FDA regulated product Question Feedback: This type of "advertising" would fall under the category of a "help-seeking" advertisement because the product is not named, although it likely makes recommendations about actions that might be taken based on a particular symptom, i.e., low or elevated glucose levels. Unlike drug and device promotional labeling and prescription drug and restricted device advertising, disease awareness communications are not subject to the requirements of the FD&C Act and FDA regulations. For which device below does the Quality System Regulation require the same procedures for identifying the control number for each unit, lot or batch of finished devices as those mandated by the new UDI Rule? A. Surgical gloves B. X-ray machines C. Pacemakers D. Syringes - C. Pacemakers Question Feedback: According to 21 CFR 820.65,"Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components." The Pacemaker is a Class III implantable device and subject to 21 CFR 820.65. (Sec. 820.65 Traceability- Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR.) Your company is developing a new drug to be developed and used in combination with a cystoscopic light device for the early detection of bladder cancer. You are asked to develop an overall regulatory strategy. The first step you undertake is:A. Submit a Request for Designation to FDA Office of Combination Products for determination of the lead center for primary jurisdiction for the combination product. B. Make a preliminary internal company determination of the combination product's primary mode of action. C. Submit an IND along with a Request for Designation to FDA CDER Office of Oncology Drug Products (OODP). D. Submit a request for designation to FDA CDRH and notify the Office of Combination Products - B. Make a preliminary internal company determination of the combination product's primary mode of action. Question Feedback: It is important to determine the primary mode of action first to be able to make a recommendation as to which agency component should have primary jurisdiction, to be followed by a request for designation to FDA OCP if deemed necessary when the product's classification or the agency center to which it should be assigned in unclear or in dispute. A key pharmaceutical product parameter has a specification range of 90-100. Which of the following postmarketing specification changes would require FDA notification prior to making the change? A. 89-100 B. 90-99 C. 95 +/- 5 D. 95-100 - A. 89-100 Question Feedback: Notification is required when the specification range is widened. VIII. Specifications: B. Major Changes (Prior Approval Supplement) The following are examples of changes in specifications considered to have a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product. C. Moderate Changes (Supplement—Changes Being Effected) Supplement—Changes Being Effected in 30 Days b. Relaxing an acceptance criterion Which of the following statements is NOT true for Phase I Investigational New Drug (IND) Applications and Investigational Device Exemptions (IDEs) for significant-risk products? A. The investigational product must be manufactured in full compliance with CGMP B. Clinical study protocols must be reviewed and approved by an Institutional Review BoardC. The IND or IDE goes into effect 30 days after FDA receives the application, unless FDA notifies the sponsor otherwise D. The application must include an environmental impact statement that contains a claim for categorical exclusion or an environmental assessment - A. The investigational product must be manufactured in full compliance with CGMP Question Feedback: According to CFR 210, 2(c), "An investigational drug for use in a phase 1 study, as described in 312.21(a) of this chapter, is subject to the statutory requirements set forth in 21 U.S.C. 351(a)(2)(B). The production of such drug is exempt from compliance with the regulations in part 211 of this chapter." However, based on FDA guidance, Phase 1 investigational drugs should be manufactured with the application of some (not full) CGMP. What type of communication will FDA send an applicant when the review division concludes an NDA or ANDA cannot be approved in its present form and certain additional information or clarifications are needed? A. Non-approvable letter B. Complete response letter C. Non-approval letter D. Approvable letter - B. Complete response letter Question Feedback: All deficiencies identified by FDA will be in the complete response letter. The letter also will reflect the review of the entire application and/or amendments submitted. You have modified your 510(k) cleared device with a special 510(k). In which of the following cases would you need to create a new device listing for the device? A. You have added new sizes and shapes in the product portfolio B. You have changed the material composition of the device C. You have changed the package of the device D. You have added an additional device under a different name with the same intended use and indication for use but with a minor change to its physical characteristics - D. You have added an additional device under a different name with the same intended use and indication for use but with a minor change to its physical characteristicsQuestion Feedback: From 21 CFR 807.22(b): (b) Registration and listing updates. Owners or operators shall review and update all of their establishment registration and device listing information that is on file at FDA, documenting any changes that were not previously reported as follows: (1) Annual registration for each fiscal year is required for all establishments. Annual registration shall take place during the period beginning on October 1 and ending on December 31 of each fiscal year; (2) Updates to the registration information as described in 807.25(b) shall be made within 30 days of any change to such information; (3) Every fiscal year, during the period beginning on October 1 and ending on December 31, owners or operators shall review and update all of their device listing information that is on file at FDA, reporting any changes or deletions to listings and any new listings that were not previously reported. The accuracy of all information on file must be confirmed each year regardless of whether any changes were made to the owner or operator's list of devices; and 4) Changes to listing information may also be made at other times, such as when a device is introduced into commercial distribution, when a change is made to a previously-listed device, or when a previously-listed device is removed from commercial distribution. What is a major difference between an HDE application and a PMA application? A. Application form and content B. Labeling requirements C. Supplemental applications D. Effectiveness requirements - D. Effectiveness requirements Question Feedback: Effectiveness requirements are not included in an HDE application. Sec. 814.3 Definitions. m) HDE means a premarket approval application submitted pursuant to this subpart seeking a humanitarian device exemption from the effectiveness requirements of sections 514 and 515 of the act as authorized by section 520(m)(2) of the act. (e) PMA means any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference therein. "PMA" includes a new drug application for a device under section 520(1) of the act. Five-year exclusivity for a chemical compound, sometimes called New Chemical Entity (NCE) exclusivity, prevents the approval of all of the following for five years EXCEPT: A. A generic application for the approved active ingredient B. A generic application for a salt of the approved active ingredient C. A generic application for an ester of the approved active ingredient D. A Section 505(b)(1) New Drug Application (NDA) for the same drug - D. A Section 505(b)(1) New Drug Application (NDA) for the same drugQuestion Feedback: NCE exclusivity prevents the approval of a generic application for the approved active ingredient or any salt or ester of the approved active ingredient for five years. However, five-year exclusivity does not prevent FDA from approving, or a company from submitting, a full Section 505(b)(1) NDA for the same drug. Small Business Assistance: Frequently Asked Questions for New Drug Product Exclusivity (FDA website) 1. What is new drug product exclusivity? New Drug Product Exclusivity is provided by the Federal Food, Drug, and Cosmetic Act under section 505(c)(3)(E) and 505(j)(5)(F). Exclusivity provides the holder of an approved new drug application limited protection from new competition in the marketplace for the innovation represented by its approved drug product. This limited protection precludes approval of certain 505(b)(2) applications or certain abbreviated new drug applications (ANDAs) for prescribed periods of time. Some exclusivity provisions also provide protection from competition by delaying the submission of 505(b)(2) applications and ANDAs for certain periods of time. Full new drug applications under 505(b)(1) and 505(b)(2) can receive 5 years of exclusivity for a new chemical entity drug product. A 505(b)(1), 505(b)(2) application or a supplement to a new drug application can receive 3 years of exclusivity. 21 CFR 314.108—New drug product exclusivity. (b) Submission of and effective date of approval of an abbreviated new drug application submitted under section 505(j) of the act or a 505(b)(2) application. (1) [Reserved](2) If a drug product that contains a new chemical entity was approved after September 24, 1984, in an application submitted under section 505(b) of the act, no person may submit a 505(b)(2) applicati A blood center has discovered a unit of packed red blood cells for commercial use previously shipped to a local hospital was stored inappropriately for four days during the manufacturing process. The blood center should: A. Recall the blood product and initiate a blood product deviation report to CBER within 45 calendar days of discovery of the deviation. B. Recall the blood product and initiate a blood product deviation report to CDRH within 45 calendar days of discovery of the deviation. C. Recall the blood product and initiate a blood product deviation report to CBER within 15 calendar days of discovery of the deviation D. Recall the blood product and initiate a blood product deviation report to CDRH within 15 calendar days of discovery of the deviation. - A. Recall the blood product and initiate a blood product deviation report to CBER within 45 calendar days of discovery of the deviation. Question Feedback: CBER is the FDA branch handling biologic products and the appropriate reporting period is 45 days from discovery of the manufacturing deviation. Under 21 CFR 606.171, a manufacturer is required to report certain events associated with the manufacturing, to include testing, processing, packing, labeling or storage, or with blood or blood component holding or distribution, which may affect the a distributed product's safety, purity or potency. Safety, purity and potency are defined in 21 CFR 600.3(p), (r) and (s). Under 21 CFR 606.171(c), a manufacturer should submit reports as soon as possible,but is required to submit reports at a date not to exceed 45 calendar days from the date of discovery of information reasonably suggesting a reportable event has occurred. To be approved by FDA, a generic drug must be therapeutically equivalent to the branded product with the exception of: A. Dosage Form B. Route of Administration C. Inactive Ingredient(s) D. Labeling - C. Inactive Ingredient(s) Question Feedback: The law requires generic drugs approved by FDA TO have the same active ingredient(s), dosage form, strength, route of administration, labeling, and conditions for use as the branded product, and that the generic and branded drug be bioequivalent. The inactive ingredients can be different. Sec. 314.92 Drug products