Regulatory Agencies

Question 1

List of regulatory and standard agencies

Answer 1

FDA
CDC
CMS
AAMI
ANSI
APIC
DOT
EPA
OSHA
TJC
WHO

Question 2

Regulation

Answer 2

Mandated by the government and required by law

Question 3

U.S Food and Drug Administration (FDA)

Answer 3

Ensures medical devices are safe and effective

Regulates medical device manufacture, sterilants, disinfectants, packaging, sterilizers, biological indicators, and single-use devices

Question 4

Centers for Disease Control and Prevention (CDC)

Answer 4

The Federal agency promotes health by preventing diseases, injuries, and disabilities by responding to health emergencies

Question 5

U.S. Environmental Protection Agency (EPA)

Answer 5

Regulated environmental aspects, including emissions, waste reuse, and chemical regulations.

Sets emission standard for ethylene oxide (EO) sterilization.

Question 6

Occupational Safety Health Administration (OSHA)

Answer 6

Protects workers from occupational hazards.

Question 7

Standard

Answer 7

A set of recommended rules or processes for an organization or department to follow.