Semester.ly

Johns Hopkins University | EN.580.607

Regulation of Medical Devices

1.0

credits

Average Course Rating

(3.83)

This course introduces graduate students in Bioengineering Innovation and Design to the medical device regulatory framework, as it pertains to bringing a medical device from concept to market. Topics covered include; FDA Design Controls; Regulatory Approval mechanisms, including the 510k and PMA process; Investigational Device exemption (IDE); planning clinical trials needed for bringing a medical device to market; and postmarket surveillance. Students learn from a series of invited lecturers from the FDA as well as professionals from the medical device industry. This summer course is required for CBID masters students and is not open to any other students.

Fall 2013

(3.47)

Fall 2014

(4.18)

Fall 2013

Professor: Soumyadipta Acharya

(3.47)

Students believed that the best aspect of this course was having access to FDA officials so they could receive feedback and input on their projects. Students liked the lectures, and they found that the 38 information they learned was interesting. Some of the lectures were repetitive, so students suggested regulating the speakers to talk on specific, complementary but non-overlapping subjects. Prospective students should be prepared to attend class with questions for the lecturers and take notes on what they learn.

Fall 2014

Professor: Soumyadipta Acharya

(4.18)

Students praised this course for giving students an opportunity to learn from various guest lecturers including ones from the FDA that gave students insight on various regulatory issues. Students’ issues with the course included a belief that the informal nature of the course meant that lecture content could overlap and become repetitive. Suggestions for improvement included a desire by multiple students that the course overal would be better if there was greater coordination between the various instructors so topics weren’t repeated. Prospective students should know that students found the course was a good window into the workings of the FDA. They also found it helpful to have some previous knowledge about regulatory bodies and how they work.