Legal Basis for Medical Device Product Regulation

General

Prefix

RAS

Course Number

621

Course Level

Graduate

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

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: