Hello Shubhajit
In my experience, your company should determine how to define "device type" for your specific device and be prepared to defend it. FDA currently requires annual reporting for devices that are released to the market under the custom device exemption.
Best Regards, Lauren
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Lauren Kamer RAC
Director of Regulatory
United States
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Original Message:
Sent: 24-Apr-2019 10:28
From: Shubhajit Mitra
Subject: Custom Made Device
Hello Members,
Is anyone here with prior experience on custom made devices? I would appreciate if anyone could provide me some insight on the regulations behind custom made device. My interpretation of the custom made device guidance is that we cannot sell or make no more than 5 devices per device type in an year. If we are using multiple devices of a device type to treat a patient in different anatomical locations then it will be accounted as one device. Also, if multiple devices of a device type are used in a same anatomical location then it will be considered as one device.
Am I interpreting the no more than five units per year of a device type correctly? What are the other regulatory challenges around custom made devices?
FDA guidance on custom made devices- https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm415799.pdf
Thank you,
Kind regards,
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Shubhajit Mitra
Senior Regulatory Affairs Specialist
Hopkinton MA
United States
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