Hi Robert,
I agree with the feedback from the others.
The following is from FDA guidance (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134573.htm#criteria):
Criteria for a Special 510(k)
Under the New 510(k) Paradigm, a manufacturer should refer to 21 CFR 807.81(a)(3) and the FDA guidance document entitled, "Deciding When to Submit a 510(k) for a Change to an Existing Device," to decide if a device modification may be implemented without submission of a new 510(k). If a new 510(k) is needed for the modification and if the modification does not affect the intended use of the device or alter the fundamental scientific technology of the device, then summary information that results from the design control process can serve as the basis for clearing the application along with the required elements of a 510(k) found in 21 CFR 807.87.
To optimize the chance that a Special 510(k) will be accepted and promptly cleared, 510(k) submitters should evaluate each modification against the considerations described below to insure that the particular change does not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
(Be aware that the referenced guidance document is from 1997; there is a newer draft of this document which Roger kindly linked earlier.)
The guidance also states the following, which may be of interest to you as you indicated that your product is an implant:
In addition, FDA is concerned with changes in materials in certain devices. While FDA acknowledges that many such changes can be processed as Special 510(k)s, there are certain types of changes in materials that may raise safety or effectiveness issues that continue to warrant a more intensive evaluation. This includes a change in material(s) in an implant, or other device that contacts body tissues or fluids, to a material type that has not been used in other legally marketed devices within the same classification regulation for the same intended use (i.e., "legally marketed predicate device").
Following up from what Ginger and David said, I would say that it is possible to submit a Special (providing a clear rationale as to why the fundamental scientific technology of the product is not altered per the guidance), however I think that there is a good chance that your submission could get converted to a Traditional 510(k). You could consider different plans, as Ginger mentioned, which may include submitting a Special but preparing the additional documentation required for a Traditional while your submission is under review to minimize any response time if your submission were to be converted. I have minimal experience with Special 510(k)s, but the ones that I have seen did get converted, although it would have been under a different review division than your product.
Hope this helps!
Liz
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Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
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Original Message:
Sent: 16-May-2017 18:20
From: Robert Nami
Subject: Which 510k would be appropriate? Special or Abbreviated?
If a manufacturer of preface abutments has a 510k for a Cobalt-Chromium (CoCr) type of the product and would like to now get clearance for a Titanium (Ti) version of the same device, can it be done through a Special or Abbreviated 510k? If so, which would be more appropriate?
A preface abutment is a regulated product that is milled (machined) into an abutment which is placed on a dental implant inside patient's mouth.
Of interest to regulators, is the design and integrity of the portion of the abutment which mates with the implant.
The only difference in this case is a material change. There is significant data available for on both CoCr and Ti preface abutments.
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Robert Nami
Carlsbad CA
United States
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