#23: A Device Primer: 510(k)s, PMAs, IDEs Day & Time:
June 23, 8:30AM - 12:00PMInstructor(s):
Barry S. Sall, RAC
PAREXEL Consulting, United StatesDescription:Maximize your learning while attending the DIA 2013 49th Annual Meeting! Receive $100 off of your DIA 2013 meeting registration by registering for two half day tutorials or one full day tutorial. Purchases must be made at the same time in order to receive the discount.
Get up to speed on medical device clearances and approvals! This tutorial demystifies FDA's medical device requirements. We will explain the medical device development process, 510(k)s and PMAs, as well as discuss IDE requirements. Attendees will use that information to determine the appropriate pathway for a fictional product 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.
|#23: A Device Primer: 510(k)s, PMAs, IDEs ||CME|
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.Target Audience:
This tutorial is designed for regulatory affairs (RA) managers, business development managers and staff; principal investigators, IRB members, clinical research associates (CRAs), academic sites; lawyers, R&D, and those working on combination products, cross-functional medical products and those wishing an introduction to devices.