Regulatory Routes to Market: 510(k)s

General

Prefix

RAS

Course Number

623

Course Level

Graduate

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

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: