Regulatory Open Forum

Dear RA Experts:

I have following query, that is little bit tricky.

We have one cleared 510 (k), and now we want one additional part under that product, but that product was not listed initially in the devcie list of 510 (k) while Initial application.
Also the part do not add any new risk or change/modify device intended use, so in this case would it be necessary to apply for FDA accessory application? as the part can be categorized as suppement part, or we can go for letter to file for that as well?

I would really appreciate your valueable input.

Thanks,

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Rabel Talpur
Freiburg
Germany
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It looks like this question may be a duplicate.  Accordingly a response has been lodged to the other duplicate here.

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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 29-Jul-2022 10:35
From: Rabel Talpur
Subject: Categorization of additional part in already cleared 510 (k)

Dear RA Experts:

I have following query, that is little bit tricky.

We have one cleared 510 (k), and now we want one additional part under that product, but that product was not listed initially in the devcie list of 510 (k) while Initial application.
Also the part do not add any new risk or change/modify device intended use, so in this case would it be necessary to apply for FDA accessory application? as the part can be categorized as suppement part, or we can go for letter to file for that as well?

I would really appreciate your valueable input.

Thanks,

------------------------------
Rabel Talpur
Freiburg
Germany
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