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RAC Exam/97 Answered Questions/100% Accurate
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- RAC Exam/97 Answered Questions/100% Accurate
RAC Exam/97 Answered Questions/100% Accurate
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RAC Exam/97 Answered Questions/100%Accurate
drug - -Any article intended for use in the diagnosis, cure, mitigation,
treatment or prevention of disease in man.
-medical device - -An instrument, apparatus, implement, machine,
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 other 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 - -Drug Registration and Listing System
-FURLS - -FDA Unified Registration and Listing System for establishment
registration of medical device operators and distrubutors).
-eDRLS - -electronic Drug Registration and Listing System
-MDUFMA - -Medical Device User Fee and Modernization Act 2002. Required
electronic medical device event reporting.
-MDR - -System used for event Reporting for device manufacturers and
importers
-Importer - -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 repackage, 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 all 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 manufacturer 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 - -Changes the content of the labeling from that supplied from
the original manufacturer 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 - -Packages finished devices from bulk or repackages devices
made by a manufacturer into different containers (excluding shipping
containers).
-Device User Facilities - -A "device user facility" is a hospital, ambulatory
surgical facility, nursing home, outpatient diagnostic facility, or outpatient
treatment 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 Adverse
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 document issued by FDA.
-Manufacturer and User Facility Device Experience (MAUDE) database - -
contains mandatory reports filed by manufacturers and importers from
August 1996 to present, all mandatory user facility reports from 1991 to
present, and voluntary 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.
-pharmacokinetics - -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 - -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 effect.
-CFR - -has 50 titles; official compilation of regulations; updated yearly
-Federal Register - -Daily supplement to CFR
, -Food, Drug and Cosmetic (FD&C) Act - -1938 and subsequent Acts; basic
Food & Drug Law. Came about after the sulfanilamide contamination that
killed a bunch of kids. Strengthened safety and labeling. Still only focused on
safety (not yet efficacy).
-NAI - -No Action Indicated
-OAI - -Official Action Indicated
-VAI - -Voluntary Action indicated
-EIR - -Establishment Inspection Report - FDA summarizes the inspection
and classifies it as NAI, VAI, or OAI.
-482 Form - -FDA gives for official inspection notice
-483 Form - -inspection findings; have 15 days to respond with correction
plan
-RFD - -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 receipt (Request for Reconsideration).
-Pediatric Research Equity Act (PREA) - -Mandatory Pediatric studies
-4 Categories of Communication from FDA - -1. Administrative meetings or
communications
2. Product application meetings
3. regulatory communications (e.g., guidance docs, citizen petitions, etc.)
4. Public administrative proceedings.
-Type A meeting - -critical meeting (For drug approval) to address a stalled
development (e.x, SPA mtg, post-action meeting, dispute resolution). Held
within 30 days of FDA's receipt of written request from Sponsor. FDA notifies
Sponsor of the date within 14 days of request.
-Type B meeting - -pivotal meetings; End of Phase 1, End of phase 2, pre-
IND, NDA, pre-BLA, post marketing and REMS. Scheduled within 60 days of
request. FDA notifies Sponsor of the date within 21 days of request.
-Type C meeting - -other meetings that are not A or B; Scheduled within 75
days of request. FDA notifies Sponsor of the date within 21 days of request.
-1906 Food & Drug Act - -prohibited the marketing of adulterated
(contaminated) and misbranded food and drugs. Did NOT require product
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