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BME59500 - Regulatory Issues Surrounding Approval of Biomedical Devices

Spring 2014

Days/Time: T / 4:30-7:20 pm
Credit Hours: 3

Learning Objective:
None

Description:
This course concerns the processes for obtaining FDA marketing approval for biomedical devices. Prior to marketing a medical device in the US specific governmental approval is required. Approval processes for class I, II, and III devices, including combination devices, are covered with specific focus on 510K and PMA requirements.

Topics Covered:
Spring 2014 Syllabus Course Introduction; classification overview; 510K regulations and process; letter to file; special submissions; PMA regulations, content, strategies, and processes; labeling and claim language; supplementals and annual reports; combination devices; HDE, HUD, and pediatric approvals, STED and CER.

Prerequisites:
None required.

Web Address:
http://www.itap.purdue.edu/learning/tools/blackboard/

Homework:
There are 7 or 8 written assignments, accepted via email at aob@purdue.edu.

Projects:
There is a group presentation required. Distance students participate via the Internet by video conference, internet conference, or by phone. Interactions with team members will be by email and Internet as well.

Exams:
None.

Textbooks:
*Tentative-check the Office of the Registrar Textbooks for the official list*
No texts required.

Computer Requirements:
ProEd Minimum Computer Requirements

ProEd Minimum Requirements: view

Tuition & Fees: view

Other Requirements:
None

Andrew O. Brightman
Phone
765-496-3537
Email
aob@purdue.edu
Office
Purdue University
Martin C. Jischke Hall
206 S Martin Jischke Dr
West Lafayette, IN 47907-2032
Fax
765-494-1193
Instructor HomePage