Federal Government & Medical Devices

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


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