Full details about the specific nature of the existing devices and parts, and precisely how they were described in the existing 510(k), compared to the new part, are needed before a full and proper answer is possible for your question.
But as a general rule, if the new part can reasonably be considered to have been realized via a modification of the existing 510(k)-cleared product or its 510(k)-cleared parts, and if that modification meets the criteria in
this FDA guidance document, then no new 510(k) is needed. Instead, the new part could, via a letter to file, be bundled within the scope of authorization represented by the existing bundle of parts in the existing 510(k). But as you said, that can be a tricky endeavor. Consequently, the full details of your case need to be carefully screened and assessed by a qualified medical device 510(k) regulatory professional in order to maximize the integrity of the resulting regulatory strategy.
Finally, you mentioned the term "accessory". That is a very particular and sensitive term with the FDA. Accordingly, be sure that you've given due attention to FDA's approach to medical device "accessories". Specifically, if the new part truly is an "accessory" (see
FDA's approach to accessories here) the basic type and nature of which wasn't clearly defined and included in the existing 510(k), then that would generally disqualify the part's eligibility for inclusion under the existing 510(k).
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 29-Jul-2022 10:36
From: Rabel Talpur
Subject: Additional part for already 510 (k) cleared Medical device
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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