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BMEN 253 Quiz Qs
Terms in this set (20)
The FDA's system to classify Medical devices as either CLASS I, II, or III is (best answer)?
Based on the degree of risks associated with the use of the device to patients and providers
Which of the following is ALWAYS required of a legally-marketed CLASS I medical device?
Following General Controls
Which of the following must be proved to obtain a PMA (what is the 'Standard' used in approval)?
The product's reasonable assurance of overall safety and (clinical) effectiveness
4. Which of the following must be proved to obtain a "510K" (what is the 'Standard' used by the FDA in acceptance)?
Substantial equivalence to a predicate device with regard to safety and (clinical) effectiveness
What is the working definition of what represents a well-selected predicate device? (best answer)
a. A device already "passed" by FDA for the same indication for use, or marketed before the MDAs
c. A device with similar technical characteristics to your device or for which the technical characteristics do not introduce new and different risks
Which of the following generally is NOT true regarding the QSR (Quality System Regulation) system in the USA?
It outlines virtually all of the federal power for FDA
The FDA's QSRs are not strictly "prescriptive". However, a firm's QMS (Quality Management System) needs to fully account for which of these three characteristics in its design and implementation if its QMS is to comply with the FDA's QSR intent (best answer)?
Risk presented by the device, Complexity of device and how it is made, Size and complexity of organization
Which of the following lists includes ONLY activities which per the 'basic requirements' of a firms QMS need to be covered (best answer)?
Design, Manufacture, Packaging, Labeling
In the "FDA waterfall diagram", verification is the process of checking concurrence between
Design Outputs and Design Inputs
In the FDA waterfall diagram, validation is the process of checking concurrence between
The Medical Device as designed and User Needs
The following is a good example for a User Requirement (best answer):
Stent shall be able to provide a scaffold for short and medium length atherosclerotic coronary lesions, but need not address diffuse CAD and long lesions
Stent shall possess a means to impede excess cellular proliferation
The following is a good example for a Design Input (best answer):
Stent shall be able to cover lesions from 3mm in length to 8 mm in length
The following is a good example for a Design Output (best answer):
Stent shall be manufactured in lengths of 4, 5, 6, 7, 8, 9, and 10 mm (each to be +/-0.05mm)
What are two necessary and vital component elements under proper to design controls (best answer):
Document Controls and Change Controls
When should Design Controls be implemented in the design and development of medical devices?
After proof of concept is completed
Why do companies have "mission statement" ( best answer)
Create an ethical framework to manage their business
True or False 510 K is the most common pathway to market for a class II device
True or False Class 1 medical are not subject to design controls
True or False 21 CRF 820.30 refers to Quality System Regulations (QSR)
True or False Class 4 medical device have the most risk
Sets found in the same folder
BMEN 253 Intro to FDA
BMEN 253 Design Controls
Usability - Lecture 6
BMEN 253 Exam 1
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