VA Level 2 SPS Training IAHCSMM Regulations and
Standards 2025
What term defines as a mandatory law or rule that is issued by a governing body. -
ANS-Regulation.
What term defines a uniform method of defining basic parameters for processes,
products, services, and measurements. Examples: Regulatory and Voluntary. - ANS-
Standard
What is the purpose of regulations and standards and standards?
A. To establish minimum levels of quality, safety, reliability, efficiency, and
interchangeability for the products and services needed.
B. Cost savings
C. Provide guidelines.
D. Assure Consistency.
E. All of the above. - ANS-E. All of the above.
Compliance with regulations is issued by which federal, state, and local governing
bodies?
A. FDA, OSHA only.
B. FDA, OSHA, EPA, and DOT.
C. FDA only.
D. None of the above. - ANS-B. FDA, OSHA, EPA, and DOT.
T/F: The FDA (Food and Drug Administration) is a federal agency responsible for
ensuring that foods, cosmetics, human and veterinary drugs, biologicals products
medical devices, and electronic products that emit radiation are safe and effective for
public's use. - ANS-True
FDA Class 1 is ______ (fill in the blank).
A. A device that poses low risks.
B. A device that poses potential risk.
C. A device that poses the highest risk. - ANS-A. A device that poses low risks.
FDA Class II is _______ (fill in the blank).
A. A device that poses low risks.
B. A device that poses potential risk.
C. A device that poses the highest risk. - ANS-B. A device that poses potential risk.
Standards 2025
What term defines as a mandatory law or rule that is issued by a governing body. -
ANS-Regulation.
What term defines a uniform method of defining basic parameters for processes,
products, services, and measurements. Examples: Regulatory and Voluntary. - ANS-
Standard
What is the purpose of regulations and standards and standards?
A. To establish minimum levels of quality, safety, reliability, efficiency, and
interchangeability for the products and services needed.
B. Cost savings
C. Provide guidelines.
D. Assure Consistency.
E. All of the above. - ANS-E. All of the above.
Compliance with regulations is issued by which federal, state, and local governing
bodies?
A. FDA, OSHA only.
B. FDA, OSHA, EPA, and DOT.
C. FDA only.
D. None of the above. - ANS-B. FDA, OSHA, EPA, and DOT.
T/F: The FDA (Food and Drug Administration) is a federal agency responsible for
ensuring that foods, cosmetics, human and veterinary drugs, biologicals products
medical devices, and electronic products that emit radiation are safe and effective for
public's use. - ANS-True
FDA Class 1 is ______ (fill in the blank).
A. A device that poses low risks.
B. A device that poses potential risk.
C. A device that poses the highest risk. - ANS-A. A device that poses low risks.
FDA Class II is _______ (fill in the blank).
A. A device that poses low risks.
B. A device that poses potential risk.
C. A device that poses the highest risk. - ANS-B. A device that poses potential risk.
