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One important piece of documentation that medical device companies rely on to get them through the regulatory process is the premarket notification 510(k).

Since the FDA will refuse to accept submissions that are missing the appropriate documentation, it’s vital to understand what this is and when it is needed.

My recommendation is to include that RTA checklist... That really saves some time.” - Allison Komiyama

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Today’s guest, Allison Komiyama, PhD, RAC, is a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation.

She started her consulting practice, AcKnowledge Regulatory Strategies, in order to serve clients all over the world, large and small, who manufacture implantable and other patient-contacting medical devices.

She received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley.

You don’t want to ask for forgiveness instead of permission. You want to play by the rules.” - Allison Komiyama

Jon and Allison have a very insightful conversation on the 510(k) submission process with lots of actionable insights.

Here are some of the specific topics you'll hear discussed today:

  • What happens to new submissions at the FDA, and where the 510(k) fits in

  • The “Refuse to Accept” policy: What it means and how it can be a positive thing

  • Where the FDA stands on “I promise” statements

  • Advice for companies using materials that require biocompatibility testing

  • Tips for design controls and 510(k)

  • Biggest mistakes that Allison has seen with 510(k) documents

  • The timeframe for getting your 510(k) through the FDA, and what factors it depends on


If you found today's episode valuable, then you'll definitely get a lot out of the free webinar we're hosting with Allison where she will be diving even deeper into this topic of FDA 510(k) submissions.

In our free, 60 minute webinar, Allison will be sharing all her 510(k) submission insider tips, tricks and best practices to give you the best chance at receiving your clearance letter faster than your competitors.

Click here to sign up for the free webinar.


Links and Resources:

Allison on LinkedIn

Acknowledge Regulatory Strategies

Premarket Notification Acceptance Checklists for 510(k)

FDA Guidance for ISO 10993-1

Information on De Novo Summaries

Sign Up for Our Free Webinar!


About The Global Medical Device Podcast:


The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or SoundCloud.