Not knowing more about your particular scenario, I anticipate that FDA will require you to submit a new 510(k) (or
de novo reclassification petition) for the accessories.
The only way FDA permits new devices to be added to an existing 510(k) is if you can successfully argue that you've made a change to
your own 510(k)-cleared device, and that the new versions are not "significantly changed" [see 21 CFR 807.81(a)(3) and FDA's
corresponding guidance]. Accordingly, regarding your goal, "...
We would like to have these accessories covered under the existing 510(k) for these analyzers...", remember that this will work only if "the existing 510(k)" is your own (or, if you are a private label distributor, your OEM's). This is because each person who is required to register his establishment pursuant to 807.20 must submit a premarket notification pursuant to 21 CFR 807.81(a). The other condition for this to work is if said existing 510(k) adequately described, characterized, and substantiated (i.e., demonstrated substantial equivalence of) the accessories. If not, then a new 510(k) will be required. Remember also that 807.81(a)(3) is essentially an internal documentation exercise in which FDA is not directly involved (at least, not until such determinations are potentially reviewed during subsequent FDA inspection). Indeed, there is no actual FDA statutory/regulatory mechanism whereby an existing cleared 510(k) is revised by FDA to include additional devices that weren't included when FDA granted the original clearance.
Hope this helps,
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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.comCopyright 2017 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 11-Oct-2017 10:55
From: Anonymous Member
Subject: Bringing accessories under existing 510(k)
This message was posted by a user wishing to remain anonymous
Hello to all,
The FDA has given us 30 days to respond with a corrective action to this situation. There were some accessories we had classified as Class I exempt. However, the FDA came back to us and stated these were accessories to Class II analyzers and are thus Class II devices. We would like to have these accessories covered under the existing 510(k) for these analyzers, however I am unable to find a guidance or regulation for what would need to be done to accomplish this. Any help would be appreciated. Thank you.