A custom device has a specific regulatory definition - basically it is an unapproved device that is needed for a specific patient (or to meet the needs of a specific physician) for which there is not an alternative. Think of a very large or very small patient who needs an implant, for instance, but will not allow the marketed sizes to fit them. There are specific reporting requirements around these, and you can only distribute a limit of 5 per year of any custom device.
Customized devices, on the other hand, are approved devices that are modified slightly, within an approved range, to specifically fit each patient. Think along the lines of dental crowns, which are made from a mold of your remaining tooth to ensure fit.
One 3D printed device with 510(k) clearance that I am aware of is called StarFix. It is for ensuring accurate trajectories for things like brain biopsy. The patient undergoes imaging with a series of fiducials placed on the skull (I can't remember offhand if the imiaging is MRI or CT). These images are used to create a 3D printed device that specifically fits the patients skull shape and thus allows a neuro-surgeon to place a needle with excellent accuracy. You might want to look up their 510(k) for more details on how they defined their range of devices.
g-
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Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
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Original Message:
Sent: 13-Jun-2017 03:12
From: Aria Mijin Kim
Subject: Difference between Custom Device vs. Customized Device
Hello All,
Is there anyone who knows the difference between 'Custom Device' and 'Customized Device'. The following sentence is quoted from FDA Guidance on Technical Considerations for Additive Manufactured Devices, and it seems like the 'Custom Device' is not the same with the 'Customized Device'.
Note that while patient-matched or patient-specific devices are sometimes colloquially referred to as "customized" devices, they are not custom devices meeting the FD&C Act custom device exemption requirements unless they comply with all of the criteria of section 520(b).
Best regards
Aria
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Aria Mijin Kim
Seoul
Korea, Republic of
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