RAC Exam New Edition 2024 Solved Correctly drug - Answer ✔️✔️-Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. medical device - Answer ✔️✔️-An instrument, apparatus, implement, machi ne, contrivance, implant, in vitro reagent or similar or relate article, including any component, part or accessory intended for the use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease on man or o ther animals intended to affect the structure of any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body, and which is not dependent upon being metabolized for the achievement of its primary intended purposes (FD&C Act Section 201) DRLS - Answer ✔️✔️-Drug Registration and Listing System FURLS - Answer ✔️✔️-FDA Unified Registration and Listing System for establishment registration of medical device operators and distrubutors). eDRLS - Answer ✔️✔️-electronic Drug Registration and Listing System MDUFMA - Answer ✔️✔️-Medical Device User Fee and Modernization Act 2002. Required electronic medical device event reporting. MDR - Answer ✔️✔️-System used for event Reportin g for device manufacturers and importers Importer - Answer ✔️✔️-Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user, but does not repa ckage, or otherwise change the container, wrapper, or labeling of the device or device package. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with a ll applicable FDA laws and regulations. Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacture r if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Relabeler - Answer ✔️✔️-Changes the content of the labeling from that supplied from the original manufa cturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name. Repackager - Answer ✔️✔️-Packages finished devices from bulk or repackages devic es made by a manufacturer into different containers (excluding shipping containers). Device User Facilities - Answer ✔️✔️-A "device user facility" is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient trea tment facility, which is not a physician's office. User facilities must report a suspected medical device -related death to both the FDA and the manufacturer. User facilities must report a medical device -related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown. A user facility is not required to report a device malfunction, but can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under FDA's Safety Information and A dverse Event Reporting Program. Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA. See "Medical Device Reporting for User Facilities", a guidance docume nt issued by FDA. Manufacturer and User Facility Device Experience (MAUDE) database - Answer ✔️✔️-contains mandatory reports filed by manufacturers and importers from August 1996 to present, all mandatory user facility reports from 1991 to present, and vol untary reports filed after June 1993. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. pharma cokinetics - Answer ✔️✔️-what the body does to the drug (how metabolized). is currently defined as the study of the time course of drug absorption, distribution, metabo -lism, and excretion. pharmacodynamics - Answer ✔️✔️-what the drug does to the body (e.g . lowers blood pressure, etc. ). is the study of the biochemical and physiological effects of drugs on the body or on microorganisms or parasites within or on the body and the mechanisms of drug action and the relationship between drug concentration and ef fect. CFR - Answer ✔️✔️-has 50 titles; official compilation of regulations; updated yearly Federal Register - Answer ✔️✔️-Daily supplement to CFR Food, Drug and Cosmetic (FD&C) Act - Answer ✔️✔️-1938 and subsequent Acts; basic Food & Drug Law. Came about a fter the sulfanilamide contamination that killed a bunch of kids. Strengthened safety and labeling. Still only focused on safety (not yet efficacy). NAI - Answer ✔️✔️-No Action Indicated OAI - Answer ✔️✔️-Official Action Indicated VAI - Answer ✔️✔️-Voluntary Action indicated EIR - Answer ✔️✔️-Establishment Inspection Report - FDA summarizes the inspection and classifies it as NAI, VAI, or OAI. 482 Form - Answer ✔️✔️-FDA gives for official inspection notice 483 Form - Answer ✔️✔️-inspection findings; have 15 days to respond with correction plan RFD - Answer ✔️✔️-Request for Designation - to request a center for a combo product; FDA responds within 60 days. If not response, then request is granted. Can dispute it within 1 days of recei pt (Request for Reconsideration). Pediatric Research Equity Act (PREA) - Answer ✔️✔️-Mandatory Pediatric studies 4 Categories of Communication from FDA - Answer ✔️✔️-1. Administrative meetings or communications 2. Product application meetings 3. regulator y communications (e.g., guidance docs, citizen petitions, etc.)
