Regulatory Routes to Market: 510(k)s
General
Prefix
RAS
Course Number
623
Course Level
Graduate
Department/Unit(s)
College/School
College of Science and Engineering
Description
U.S. route to market for medical devices, the Premarket Notification of 510(k), and regulation and requirements. Best practices associated with the preparation and clearance of Premarket Notifications. Developing regulatory strategies for markets.
Prerequisites
Credits
Min
3
Max
3
Repeatable
No
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Explain the history and purpose of the 510(k) regulation and requirements; including the de novo classification process.
Outcome
Compare and contrast Traditional 510(k) submission structure and requirements, to 510(k) submission types.
Outcome
Formulate a technical Substantial Equivalence position with a predicate device.
Outcome
Identify and interpret regulations, guidance documents, and consensus standards to develop a 510(k) submission plan.
Outcome
Describe bench and clinical requirements.
Outcome
Identify and apply strategic planning to QSR-compliant post-market product design and manufacturing changes requiring regulatory assessment.
Outcome
Identify best practices associated with the operational preparation and timely clearance of Premarket Notifications.
Outcome
Analyze common additional information (AI) requests and discuss how to avoid them.
Outcome
Discuss the legal basis of Emergency Use Authorizations (EUAs).
Dependencies
Courses
RAS623
is a
prerequisite
for:
Programs
RAS623
is a
completion requirement
for: