RAS-625: Regulatory Routes to Market: PMAs

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Regulatory Affairs and Services
RAS-625: Regulatory Routes to Market:
PMAs
Course Description: This course covers the U. S. route to market for
high risk medical devices, the Pre-Market Approval Application or
PMA. The FDA’s PMA regulation and requirements are discussed in
detail. Best practices associated with the planning, preparation and
approval of PMAs are presented. Developing regulatory strategies
for market introduction are discussed.
Learning Objectives: Students will become generally
knowledgeable and know how to access detailed information about
the following.
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The history of the PMA regulation and associated FDA
guidance documents, and current PMA requirements.
Regulatory strategies, planning and preparation of new
PMAs.
The review process for new PMA including filing review,
100 Day Meeting, Panel review and labeling review.
Post-approval requirements including conditions of
approval, Post-Market Surveillance, Annual Reports and
device changes requiring PMA-Supplemental and FDA
approval.
Best practices in the planning, preparation and approval
for PMAs.
Prerequisites:
RAS-621 or experience is
support of PMA
submissions
Credits/Cost:
3 credits, $2250
When Offered:
Who Would Benefit:
Those new to regulatory affairs or
without prior PMA experience;
others supporting PMA submissions
including clinical research manager
and associates, quality, design and
manufacturing engineers, project
and marketing managers.
Fall semester
www.stcloudstate.edu/ras/schedule.asp