Which of the following describes a Class I medical device? - A low risk medical device
As a result of the Affordable Care Act, manufacturers are charged an excise tax of ____% on every
medical device sold, with a few exemptions, such as glasses, hearing aids, contact lenses and medical
devices sold in retail stores and purchased and used by non-medical personnel - 2.3%
Medical devices that don't have a predicate may be a... - Class III medical device that requires PMA
As a medical device manufacturer, what considerations do you need to take into account when
manufacturing a new device? Select all that apply - Demonstrating the clinical benefit of the device
The number of large hospitals in the region
Compensations made by cost savings
The cost of the device
The development team in a medical device company presented two requests for proposals: one for a
new hearing aid, and another for high efficiency mask filters. Which RFP would the company choose to
further develop? - The hearing aid because of no excise tax
Although miniaturization of medical devices provides a promising platform for diagnostics, they present
a challenge to the end-user because: - Cleaning and sterilization may present an obstacle for reuse
The dfMEA is the - Design risk analysis file
A DHF is - The design history file completed in Phase IV
Filing a 510(K) with the FDA demonstrates that a - Device has a legally marketed predicate
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