FDA Regulations Research Paper

Posted: September 17th, 2022

BME 214 Introduction to The FDA Regulatory Process and Its Technical Communication
Final Take Home Project Retrospective Analysis of FDA Medical Device Market Clearances/Approvals and Recalls
Spring 2016: Due Date – Thursday April 28 @ 6pm [Blackboard Submission]
Date: April 7, 2016 To: BME FDA Regulatory Process Enablers in Training From: Dr. Pizziconi (Dr. P) Subject: FDA Medical Device Regulatory Affairs – Final Take Home Project To conclude your formal introduction to FDA-regulated medical device best practices, you are charged with a culminating experience that entails the development of two mini-case reviews on US FDA CDRH approved medical device technologies. The first mini-case review will entail a succinct retrospective analysis of a class II (including De Novo) or class III medical device submission that was recently (January1, 2015 – April 14 2016) cleared or approved for marketing by the US FDA CDRH. The second mini-case review will entail the creation of a succinct forensic analysis of a previously market exempted, cleared or approved class I, II or III medical device that has been recently recalled.
Please use the FDA website resource only (www.fda.gov) and click on medical devices on the menu bar. This will take you to the Center for Devices and Radiological Health (CDRH) web resource that includes medical device Approvals and Clearance and Recalls

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