Regulatory Overview of High Risk Class III PMA Devices

1.5 CE Contact Hour

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Synopsis

In the US, medical devices are classified and regulated based on the risk profile of the device. PMA devices are the highest risk devices and require extensive review from the FDA. Regulatory pathways for different classification devices vary significantly. In this discussion you will learn about PMA Device pathway including, what goes in the PMA submission, what are PMA review process timelines/actions, PMA Post approval changes/obligations and best practices to maintain PMA product lifecycle.

Speakers:

Dr. Sanjay Sharma

Dr. Sanjay Sharma is the head of regulatory affairs for aneurysm and peripheral products at MicroVention. Over the past twenty years Sanjay held regulatory positions of increasing responsibility at various companies including, Boston Scientific Neuromodulation, Neuropace, Medtronic Neurovascular and Mainstay Medical. Prior to joining MicroVention, Sanjay worked as the VP of Regulatory Affairs and Quality at Mainstay Medical in San Diego. Prior to Mainstay Medical, Sanjay was leading aneurysm therapies regulatory portfolio at Medtronic Neurovascular in Irvine. Sanjay holds a PhD in Biochemical Engineering from Indian Institute of Technology, Delhi (India). In addition, Sanjay holds MBA from University of Illinois, Urbana Champaign. Sanjay is a RAC (US and EU) certified member of the Regulatory Affairs Professionals Society (RAPS).

Dr. Maggie Chou

Dr. Maggie Chou currently serves as RA Manager at MicroVention Terumo handling peripheral device portfolio. Prior to joining MicroVention, Maggie worked as a Principal RA Specialist at Boston Scientific, responsible for the pre-market and post-market (EU/US/CA) activities for neuromodulation implantable and non-implantable devices. Maggie had over 10 years of regulatory affairs experience including, 4 years in the pharmaceutical industry and over 6 years in medical devices. Maggie holds a PhD degree in Neuroscience and a MS degree in Regulatory Science from University of Southern California (USC), and she is a RAC certified member of the Regulatory Affairs Professionals Society (RAPS).

Moderator:

Fawn Zhang, OCRA President Elect

Location:

OCRA

Conference Room

2400 Barranca Parkway

Irvine, CA

NOTE:

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March 28, 2023

Regulatory Overview of High Risk Class III PMA Devices

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