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BME 410 Quiz 1

QuestionAnswer
What is the De Novo Pathway? For a low risk device with no predicate
What is the 510 (k) Pathway? Speedway for a new product based on it being "substantially equivalent" to a preexisting one
What is a 513(g)? A formal request for the classification of a medical device
What is a HDE? Humanitarian Device Exemption , 8,000 folks in the US a year
What did the 1976 Medical Device Amendments do? Medical Devices must be proven SAFE and EFFECTIVE
What did the 1938 Food, Drug, and Cosmetic act do? Drugs, food, cosmetics must be proven SAFE
What did the 1962 Food, Drug, and Cosmetic Amendments do? Drugs, food, and cosmetics must be proven SAFE and EFFECTIVE
What is A Drug? Chemical action or metabolism
What is a Biologic? made from living organisms ex. vaccines
What is a Combination Product? Drug + Device or Biologic + Device; Must determine PMOA
What Center is a drug application sent to? Center for Drug Evaluation and Research
What Center is a Biologic application sent to? Center for Biologics Evaluation and Research
What Center is a Device application sent to? Center for Devices and Radiological Health (CDRH)!
What means a device is FDA Approved (pathway) Premarket Approval (PMA)
What is MDUFA? Medical Device User Fees Amendment - how much it is to submit an application to FDA
Created by: RoD14
 

 



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