Federal Government & Medical Devices
This quiz covers federal government and regulatory affairs for medical devices.
Device compliance has evolved from “practices” (GMP’s) to system-based compliance. This is best exemplified in the _________ (year) publication of the .________
Answer 1: 1996
Answer 2: Quality System Regulation or QSR
FDA does NOT regulate:
Alcohol – correct
Health insurance – correct
Drugs of Abuse – correct
FDA DOES regulate:
Correct Answers:
Biologics
Drugs
Foods
Devices
Tobacco
FDA is an Agency within the Department of Health and Human Services (HHS)
True – correct
False
FDA oversees at least______________ % of the US economy:
0%
5%
25% – correct
40%
59%
For the Code of Federal Regulations (CFR) which of the following are true?
Each agency is covered by a specific title – correct
Title Three refers to the Office of the President – correct
FDA is covered by Title 21 – correct
Many Federal Agencies owe their existence to tragedies and public health incidents
True – correct
False
Medical devices are defined in several places including, The Food, Drug and Cosmetic Act (FD&C):
True – correct
False
New regulations are first published in the (Pick the best answer):
Federal Register – correct
Code of Federal Regulations
The 1996 QSR introduced a significant new section focused solely on:
Statistics
Software
Design Control – correct
Documentation
The GPO (Government Printing Office) is responsible for:
Federal Register – correct
The production and distribution of information products and services for all three branches of the Federal Government – correct
The USP has sections that are applicable to medical devices
True – correct
False.
The focus of this class is on which part of 21 CFR?
Sections 1-99 General
Sections 800-1299 Devices, miscellaneous – correct
Sections 1300 – end Controlled Substances
The three branches of Federal Government include: _________
Correct Answers
Legislative
Executive
Judicial
_____________ enacts laws in the USA.
Congress – correct
FDA budget
Correct Answers
$3.8 billion FY 2012
$4.4 billion FY 2013
what does the FDA regulate?
Correct Answers
foods
dietary supplements
human drugs
vaccines
blood products
biologics
medical devices
cosmetics
veterinary products
tobacco products