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Organization of Regulatory and Clinical Associates
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Organization of Regulatory and Clinical Associates
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HomeCurrent/Future EventsWEBINAR - 510(k) - Premarket Notifications – The Bratty Middle Child of Medical Device Submissions

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WEBINAR - 510(k) - Premarket Notifications – The Bratty Middle Child of Medical Device Submissions

Wednesday, February 9, 2022, 8:00 AM until 10:00 AM
Link will be emailed to attendees 2 days prior to the meeting, or the night prior if
registering closer to the event

Additional Info:
Event Contact(s):
ORCA Admin
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RSVP by 6:00PM Tuesday, Feb 8, 2022

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TOPIC: 510(k) – Premarket Notifications – The Bratty Middle Child of Medical Device Submissions

TOPIC DESCRIPTION: On an annual basis, the medical device industry submits around 8,000 510(k) submissions to the FDA to obtain clearance to bring a medical device to market. These are a unique pathway and with recent changes to the requirements for a 510(k) they just got a bit more confusion.

What is a 510k? How long does a 510(k) take? When should I use a 510(k)? Why does it have such a dumb name?

During this presentation, we’re going to talk about 510(k) submissions to the FDA. We’ll cover the following topics:
  • What are the types of 510(k) submissions and when is each one appropriate?
  • What goes into a 510(k) and how do I structure the submission?
  • What is the regulatory window for a 510(k) and then how long does it really take?
    Do I need to do clinical trials for a 510(k)?
  • How much will this end up costing me?
  • Everyone keeps saying ‘What is your predicate?’ What does this mean? What if I don’t have a predicate? Are there 510(k) submissions that don’t use predicates?

SPEAKER: David Hammond

SPEAKER BIOGRAPHY: David Hammond has worked in the FDA regulated field for 25 years. He started as a clinical research coordinator first in Boise, Idaho, and then in Seattle. After deciding it was time for a change, he moved to the medical device industry. While working as a clinical research associate for a Class 3 medical device trial, he found that he really enjoyed things that plug in to things that you swallow (DISCLAIMER: he does not recommend swallowing the things that are plugged in). He spent the next decade working for a series of medical device companies and through a series of job changes that he thought were well thought out, but were viewed by his parents as the sign of someone who gets bored easily, he found himself unemployed in 2008 after being laid off when his employer underwent downsizing. This led to David deciding that his next adventure would be consulting, so with absolutely no planning, he began consulting with local biotechnology companies until, as he said, he found a real job. Thirteen years and zero real jobs later, he still consults among other activities. He is currently the principal consultant (well, really the only consultant) at Hammond Clinical Trial Consulting, the VP of Clinical, Regulatory, and Quality at MagForce USA (a nanomedicine company focusing on prostate cancer), Associate Teaching Professor in the BRAMS program at the University of Washington where he gets to tell bad jokes to students and they have to laugh if they want to pass, and the Director of the Office of Research Integrity and Chair of the IRB at Bastyr University.

WHO: Clinical, regulatory, quality, manufacturing and legal

Attendance at this meeting may be applied as 1.5 points towards RAC re-certification

All attendees must be registered. Access to education content is a benefit of membership or guest attendance. The link to the webinar is intended for the registered person ONLY and any access/distribution of materials beyond the individual registrant is strictly prohibited. Viewing rights are not transferable and cannot be combined by multiple parties without express permission. Thank you for your understanding.
This webinar will be recorded.