Which of the following may be true for a significant risk (class III) medical device? (check all that apply) --Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject --Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject --Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject --Presents a potential for serious risk to the health, safety, or welfare of a subject
Which of the following may be true for a significant risk (class III) medical device? (check all that apply) --Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject --Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject --Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject --Presents a potential for serious risk to the health, safety, or welfare of a subject
Human Anatomy & Physiology (11th Edition)
11th Edition
ISBN:9780134580999
Author:Elaine N. Marieb, Katja N. Hoehn
Publisher:Elaine N. Marieb, Katja N. Hoehn
Chapter1: The Human Body: An Orientation
Section: Chapter Questions
Problem 1RQ: The correct sequence of levels forming the structural hierarchy is A. (a) organ, organ system,...
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Regulations/research help:
True or false: Industry-sponsored clinical trials are legally required to only use clinical outcome measures that have been prospectively validated.
Which of the following may be true for a significant risk (class III) medical device? (check all that apply)
--Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject
--Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject
--Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject
--Presents a potential for serious risk to the health, safety, or welfare of a subject
Expert Solution
Introduction
The FDA in 1976 have established 3 regulatory classes of medical devices- class 1 , 2 and 3.
These classes are introduced based on the risk they possess, from low to moderate to high.
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