#24: A Device Primer: 510(k)s, PMAs, IDEs

Tutorial name:
#24: A Device Primer: 510(k)s, PMAs, IDEs

Day & Time:
June 24, 8:30AM - 12:00PM

Room Number:

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Get up to speed on medical device clearances and approvals! This tutorial demystifies FDA's medical device requirements. We will explain and provide a decision matrix for 510(k)s and PMAs, as well as a matrix to clarify IDE requirements. Attendees will use that matrix to determine the appropriate pathway for public record/fictional products and explore the strategic implications behind the submission and its indications. We will examine investigational device exemptions, and discuss the role of IRBs and the level of FDA oversight as the trial proceeds.

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:

• Distinguish between 510(k)s and PMAs and their strategic advantages

• Describe the scope of IDEs (exempt, nonexempt, SR)

• Explain the nature and type of IRB including sponsor oversight

• Identify major risks and the impact of new regulatory initiatives

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