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HSPA CHL CHAPTERS 9-12 PRACTICE EXAM QUESTIONS AND ANSWERS.docx

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HSPA CHL CHAPTERS 9-12 PRACTICE EXAM QUESTIONS AND ANSWERS.docx

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HSPA CHL CHAPTERS 9-12 PRACTICE
EXAM QUESTIONS AND ANSWERS
Which of the following does not qualify under the Family and
Medical Leave Act (FMLA) -
correct answer ✅The decision to participate in a union work
stoppage


During a lawsuit regarding the processing of a medical device, an
expert witness evaluates the processing of the device according to
which of the following best practices? -
correct answer ✅Association for the Advancement of Medical
Instrumentation (AAMI) standards


Who should complete MedWatch forms when a problem is
discovered in or with a medical device? -
correct answer ✅The healthcare professionals


What is an FDA 510(k) premarket notification? -
correct answer ✅A comprehensive package of information
designed to demonstrate that the new product is "substantially
equivalent" to one or more medical devices already being marketed


Which agency regulates general-purpose disinfectants intended for
use with medical devices? -
correct answer ✅U.S. Environmental Protection Agency (EPA)

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