BME 338 SIU Circumstance Under a Medical Device Firm Issue Public Warning Responses

Hi,

You will find the files help you to answer this questions.

I have this assignment I need answer this questions:

1. Reading material for this week discussion: FDA’s Guidance to Industry “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C”
   1. Question #1: under what circumstance should a Medical Device Firm issue public warning?
   2. Question #2: Who is responsible to prepare the public warning?
2. Understand and discuss the Classifications of Medical Devices with example of device and their risk associated with each Class:
   1. Class I
   2. Class II
   3. Class III
3. Understand FDA 510(k) and its application, students shall fill this form for their Project “design, invent, or modify existing or new healthcare related Medical Facility and Medical Device”