What are the three essentials of an effective presentation? - - know your audience
- prepare
- be ready to improvise
In order to establish authority & credibility you need to be able to:
a) not exceed the time limit
b) have good graphical presentations
c) know the strengths & weaknesses of the research data you are presenting
d) be able to improvise - c) know the strengths & weaknesses of the research data you are presenting
Three major functions of regulatory affairs? - - serving as liaison between device/pharma companies &
the FDA
- submitting required paperwork to regulatory agencies both pre-& post-launch for review of
promotional materials
- reviewing data that will be published in manuscripts, & materials presented at congresses
In the device industry, regulatory affairs oversees regulations regarding _____, _____, ______, &
______. - form, fit, function, & safety
In the pharmaceutical industry, regulatory affairs oversees ________, and _______ to ensure the drug
does produced the claimed effects. - safety & efficacy
In regard to regulatory requirements with the FDA, what are the requirements of Class I? - - registration
In regard to regulatory requirements with the FDA, what are the requirements of Class II? - - clearance
- submission of Pre-Marketing Notification under 510(k) of the Food Drug and Cosmetic Act to allow the
company to proceed to the marketing and sales of the class II device
, The Pre-Marketing Notification establishes what? - ... establishes bioeqivalence to an established
predicate.
In regard to regulatory requirements with the FDA, what are the requirements of Class III? - - approval
- Pre-Marketing Application must provide all clinical data demonstrating safety
General requirements of the FDA are found in... - the Title 21 of the Code of Federal Regulations
In what section of the Title 21 of the Code of Federal Regulations can one find "Medical Device
Classification Procedures?" - 860
In what section of the Title 21 of the Code of Federal Regulations can one find "Procedures for
Performance Standards Development?" - 861
In regard to medical device classification, what are the major differences between Class I and II? - - Class
II, though presumed to be safe, require 510k and require additional testing of form, fit, function, and
safety of device
In regard to medical device classification, what are the major differences between Class II and III? - Class
III requires a Pre-Marketing Application that includes clinical trials and evaluation of results
The FDA implements testing in accordance with what program procedures? - International Organization
Performance standards (ISO)
Why is having performance standard advantageous? - Because it may expedite the filing process as it
can be used in lieu of clinical testing
_______ is a pre-notification to the FDA that a company intends to market and sell a product that is not
already listed with the FDA. It provides a comparison between the device to be marketed and a
predicate. - The 510(k)
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