Safety, Standards, adn Quality

Question 1

What does the quality system (QS) require?

Answer 1

the manufactuer to have a written QS that is subject to periodic audit by the FDA

Question 2

In almost all jurisdictions, ____ are used for the detailed requirements used to regulate medical devices, and ____ are used to set the high-level principles.

Answer 2

standars; regulations

Question 3

What are standards published in in teh USA?

Answer 3

the Federal Register (FR)

Question 4

What does the FDA require of class I medical devices?

Answer 4

Low-risk - general post-marketing controls are sufficient to assurance of safety

Question 5

What does the FDA require of class II medical devices?

Answer 5

Moderate-risk - a combo of stnadards and guidance documents are considered sufficient

Question 6

What does the FDA require of class III medical devices?

Answer 6

high-risk - scientific evidence from well-controlled clinical trials is required to provide assurance of safety

Question 7

Medical device types are grouped into 16 specialites referred to as _____

Answer 7

panels