Chp 5 FDA Flashcards
What are Class 1 Devices?
Low-risk devices
What are class 2 Devices?
The potential risk is enough to warrant a higher level of regulation.
What type of tools are class 1 devices
Hand-held surgical instruments, and ultrasonic cleaners
What type of tools are class 2 devices?
Sterilization equipment, biological and chemical indicators.
What are class 3 devices?
Very strict devices and will cause death
What type of tools are class 3 devices?
Heart valves, pacemakers, and other life-sustaining devices.
Does a class 1 device need premarket notification approval?
Most are not needed.
Does a class 2 device need premarket notification approval?
Yes, and are needed for performance standards and postmarket studies.
Does a class 3 device need premarket notification approval?
Yes, and needs a PMA (Premarket approval)
What is an IFU?
A package containing detailed instructions on how to process and use it. Cleaning and assembly instructions.
What is a class 1 recall?
Will cause serious health problems or death
What is a class 2 recall?
The possibility that the product will cause temporary or medically reversible adverse health problems.
What is a class 1 recall?
Not likely to cause adverse health problems
Does the manufacturer have to issue a press if a recall is class 1?
Yes, and let customers know and the public know
Does the manufacturer have to issue a press if a recall is class 2?
Yes and no
