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In October 2015 I recorded my first “Learning Lunch”, and the topic was “Getting the most out of pre-submission meetings.” One of the attendees asked, “Are pre-submission meetings mandatory for 510(k) submissions.” The answer was, and still is, no. However, I did say that if you are an experienced 510(k) consultant you probably don’t need a pre-submission meeting. Just a 6 months later, the FDA made some changes that made me regret those words.
The FDA released two 510(k) guidance documents in 2016: 1) how to apply ISO 10993-1, and 2) applying human factors engineering. Those two guidance documents resulted in a large number of 510(k) deficiency letters. By 2017, I had completely changed my mind.
A pre-submission meeting should always be requested, even if there is a special controls guidance document. Now I start every new project with a 510(k) pre-submission request. In fact, I had three pre-submission meetings scheduled for the same week in January of this year.
On Thursday, February 22 I’m offering an updated live webinar on 510(k) pre-submissions (Free). Please visit the following webpage to register: http://medicaldeviceacademy.com/510k-pre-submission-webinar/.
In addition, we still have opening for our 2-day, 510(k) workshop in Las Vegas on March 21-22 ($995). To register, please visit the following webpage: http://medicaldeviceacademy.com/las-vegas-510k-workshop/.
Nelson Labs is offering a 1-day seminar the day before the 510(k) workshop on biocompatibility ($499): https://news.nelsonlabs.com/education/events/biocompatibility-testing-for-medical-devices-seminar.
Eisner Safety is also offering a half-day course on electrical safety ($200): https://www.eisnersafety.com/iec-60601-1-basics-workshop-las-vegas-20-mar-2018/.
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Dave Gaisser Looking forward to the webinar, Bob. Having found the pre-submission process very useful for a particular client several years ago, I began recommending pre-sub meetings to all my clients having new or significantly modified devices. If you ask FDA the proper questions up front, you can clear up many potential issues before the final submission, making clearance (hopefully) that much quicker.
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