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Ensuring a FDA 510(k) submission is done properly is critical to getting your medical device into the market and monetizing your development. And the speed with which you complete your submission can drive significant business value.

Timeliness is key, as is completeness and accuracy. This is the business value we seek to bring to our clients.

For one client we were able to get the submission done far ahead of schedule and in the face of the FDA doubting the ability to achieve product clearance.  We believed we could be successful and ask the FDA to work with us on the success path we could see in front of us.  The FDA agreed and because we believe in building appropriate relationships with FDA reviewers all parties experienced success.

While at the FDA for another project, we requested a brief discussion with the client’s reviewer while visiting the FDA on another matter for the simple purpose of enabling understanding.  After a very brief discussion with the reviewer, we were able to better understand how to meet the reviewer’s expectations.   The reviewer also better understood the client’s perspective and goals.  Our brief “out of process” meeting created the foundations for better communication which further accelerated the submission review and 510(k) clearance.

A collaborative and comprehensive approach to FDA 510(k) submission

If you look at the FDA as a roadblock or adversary, your mindset will influence the way your approach those interactions. MethodSense believes a collaborative and comprehensive approach to submissions delivers the best business value. A well-done 510(k), combined with confidence and positive view can greatly simplify the process.  And MethodSense continues to see this approach pay off for clients.

 

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