Which approval process is likely to be required for a new heart rate monitor which is...
Which approval process is likely to be required for a new heart rate monitor which is substantially similar to a previously approved device?
Select one:
a. 510K
b. Exempt status
c. Clinical trials
d. PMA
Homework Answers
Ans_d
because it is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants along with laboratory testing.
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