Legal Basis for Medical Device Product Regulation
General
Prefix
RAS
Course Number
621
Course Level
Graduate
Department/Unit(s)
College/School
College of Science and Engineering
Description
Upon completion of this course the students will be knowledgeable about the objective and structure of the FDA, key regulations associated medical devices, and the resources available from the FDA to aid in compliance with those regulations.
Credits
Min
3
Max
3
Repeatable
No
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Identify of the origins and history of FDA’s responsibilities: laws and regulations.
Outcome
Analyze the law and regulation decisions that have been important in establishing precedents and guiding interpretations during various stages in the life cycle of a medical device, diagnostic, or combination product.
Outcome
Identify the state and federal agencies and their regulatory authority/responsibility.
Outcome
Reflect on the current FDA regulatory climate and global relationships.
Outcome
Identify the objectives of the EU Medical Device Regulations, including the significance of replacing directives with a regulation.
Outcome
Identify recognized consensus standards and conformity assessment program to promote patient safety, advance regulatory science, and support a least burdensome regulatory framework
Outcome
Determine and employ audience-appropriate communication strategies.
Outcome
Explain relevant regulatory issues clearly and concisely.
Dependencies
Courses
RAS621
is a
prerequisite
for:
Programs
RAS621
is a
completion requirement
for: