BCMAS Study Set 3 | Questions & Answers (100 %Score) Latest Updated 2024/2025
Comprehensive Questions A+ Graded Answers | With Expert Solutions
What process minimizes redundant or conflicting standards that may have evolved independently? -
harmonization
A company in the United States has completed work on a medical device and wants to take it to market.
The device does not have a predicate device on the market but is presumed to be safe. The company
completed testing for form, fit, function, and safety. Which medical device class should be selected
when determining what FDA approval process is needed? - Class II
The triad interaction between Manufacturers, HCPs and Consumers refers to what? - A model for the
biopharmaceutical industry where HCPs are the important "middlemen"
What is the first step of the process for device development? - Device discovery and concept
To what agency/organization must companies and manufacturers report payments to physicians,
investment interests held by physicians, and transfers of value made to physician owners? - Centers for
Medicare and Medicaid Services (CMS)
At what point in a drug's lifecycle does the 20-years of patent protection begin? - The date the company
files the patent
What can be both a challenge for advisory boards and a key element to a board's success? - Preparing
and planning for a meeting, including the use of an agenda and meeting moderator
In research investigations where the investigational product may be expected to offer a valuable
treatment alternative, what are the two trial designs that can be used? - non-inferiority trial and the
equivalence trial
During the publication workflow, the medical director has analyzed the data to determine informational
gaps and has determined the scientific communication platform. The medical director has determined
they do not have enough data to support their scientific communication points. What should happen
next in the process? - Conduct Phase IV studies
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