When to Submit a 510(k) in the Product Life Cycle

C

celia4237

Dear all:

I get so confused these days about when to submit a 510(k) in the product life cycle?

Sometimes it is not practical to do the performance test and the clinical test on the production device, and i think it is permitted to perform such tests on prototypes. I also see the evidance in question 80 of the preamble of QSR820.

And after these tests, the 510(k) submission can be prepared and submitted, right? And we have to make the design change according to FDA's document <deciding when to submit a new 510(k) for the change to an exsiting device>.

That is, the 510(k) submission can be based on the tests of prototypes, What do you think about it?

Thanks.
 
C

celia4237

Thank you for your quick answer.

I think in section 807.81, there is a requirement for "when a premarket motification submission is required". And it says that "the 510(k) must be submitted at least 90 days before he proposed to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use."

What does it mean by "proposed to begin the introduction or ....." ? For a foreign company, Does it mean the time when the goods reach U.S. custom"? Or the time when goods leave the factory?
 
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M

MIREGMGR

That's actually a subtle legal question.

My conservative take would be that you must have the 510(k) issued before you take the first constructive action to market the product within US jurisdiction... such as accepting a PO to sell it to a distributor or end user, or shipping product to a US warehouse, or shipping samples to a field sales force, or showing it at a trade show, or contracting for advertisements that say or imply that the product is available.

It's possible to parse more wiggle room out of the FDA's precise wording...the pharma people do that a lot...but I don't think that's an advisable course.
 
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