Hello Thomas,
You can only submit a Special 510(k) if you are the holder (owner) of the original Traditional 510(k). If you read through the FDA's website this makes it clear what the parameters and criteria for being able to submit a Special 510(k) which being submitted by the original entity. The essence is allowing the same company (same legal manufacturer) to submit some "significant" changes to their original 510(k) without having to submit the full information under a Traditional 510(k). If your client is not the owner of the original 510(k) they would need to submit a Traditional 510(k) using the original manufacturer as the predicate device.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 17-Aug-2020 18:47
From: Thomas Lawson
Subject: Submitting a Special 510(k) on a device not your own
Thanks, Ed. That did not register with me but you are correct that it is in the guidance document for Special 510(k)s. As my grandfather used to say, if it had been a snake it would have bit me.
Thom
Original Message:
Sent: 8/17/2020 2:01:00 PM
From: Ed Panek
Subject: RE: Submitting a Special 510(k) on a device not your own
The first item on the FDA checklist for a special 510(k) is "510(k) is submitted to modify a legally marketed device (Predicate) AND the Special 510(k) submission is submitted by the manufacturer legally authorized to market the predicate device."
Wont this be an issue?
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Edward Panek
VP, QA/RA
Blue Spark Technologies
Original Message:
Sent: 17-Aug-2020 11:11
From: Thomas Lawson
Subject: Submitting a Special 510(k) on a device not your own
I have a client that a license to distribute a device with 510(k) clearance from the company that manufactures the device and was the applicant of the original 510(k). My client would like to submit a Special 510(k) for a minor change to the device but submit it in his company's name and not in the name of the company that has the original 510(k). Aside from the ethics of the issue, I am not able to find any statute that says the applicant of a Special 510(k) needs to be the owner of the device for which the original Traditional 510(k) refers. I could make the argument that the Truthful and Accuracy Statement makes the Special 510(k) submission in compliance with 510(k) regulations and it is a matter of IP or other business law to settle whether my client can distribute the device after the Special 510(k) clears. Any thoughts or experiences along this line?
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Thomas Lawson PhD
Principal Consultant
El Cerrito CA
United States
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