Only appearance and PCB are changed - Do we need to submit a new 510(k)?

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celia4237

We have changed the appreance and PCB of a originally 510(k) cleared device. Should we submit a new 510(k), for example, a special 510(k), or we just need to document our change in our design control documentation.

I have noticed that there are a guidance document"Deciding when to submit a 510(k) for a change to an exsiting device",and in the flow chart B, especially the B4-B8, i find that if we didn't change our IFU, and if cilinical data is not needed, and deisgn verification didn't rise new problem of safety and effectiveness, then we should not submit a new 510(k)?

And i think our device fit the criteria mentioned above.So a documentation is enough, is that true? If it is true, do we have to notice FDA before our new device coming into market?

Thanks a lot.
 
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celia4237

Re: Only appearance and PCB are changed--Do we need to submit a new 510(k)?

BTW, the changes forms a new device with a new name.
 
M

MIREGMGR

Re: Only appearance and PCB are changed--Do we need to submit a new 510(k)?

If the new version will be perceived by the marketplace as a new product, file a Special.

Presumably there could be a question on the part of an examiner or a user as to whether the new circuitry works identically to the old circuitry under all relevant conditions. Include verification of no change in operation plus reference to the previously established safety and effectiveness of the old version as your evidence of safety and effectiveness of the new version.
 
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celia4237

Thank you for your answer.
I think whta you said is correct. When regards with the apearance, should we submit a verification test?
 
M

MIREGMGR

When regards with the apearance, should we submit a verification test?

Usually the appearance of a product doesn't strongly affect its safety and effectiveness, at least at a primary level.

A verification would show that outputs conform to inputs and/or expectations. In this instance, that would mean that the new appearance was significantly based on the old appearance. But from a regulatory appearance, you're acknowledging by filing a Special that the new version is a new product with an intentionally changed design, related to the previous version but not identical to it.

Thus my expectation would be that the examiner, on behalf of your customers and the marketplace, won't expect its appearance to be verifiable against that of the prior version.
 
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celia4237

For the PCB change, i think its safety and effectiveness can be verified by electrical safety test(according to IEC60601-1) and eletromagnetic test(according to IEC60601-1-2), so we can submit the two test report above to prove our comformity to design control as well as risk analysis, Is that true? If i am wrong, please don't hesitate to correct me.
 
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