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Hello, Has anyone had luck submitting a non-significant notice of change to an MDDS introducing a SaMD enabled accessory?  The MDDS is also SW with AI-enabled, this change will take the device from MDDS to a Class A monitoring device.  The client wants to try to pursue it as a non-significant change. ...

Hello, I'm reaching out for a client based in TX but the work may be completed remotely.  Please reach out to me if interested… details below: The client is a vascular device startup looking for ad hoc Regulatory assistance as they have a device that may require a PMA or De Novo.  Currently, the ...

Hello, Per Emergo Group, I found timelines below: Swiss manufacturers, (or their ARs and importers) must register themselves with Swissmedic within three months after placing a device on the market (see Article 55). Article 104a of the amendment provides for extra time for designating the Swiss ...

Hello, For AI devices, the algo change may/may not trigger a new submission.  Have you reviewed the Artificial Intelligence and Machine Learning Discussion Paper?  It provides a few scenarios to help make your determination.  https://www.fda.gov/medical-devices/software-medical-device-samd/artifi ...

Hello, From your description, it sounds like the individual components included in the "group of medical devices" may also be considered devices.  If yes, the individual components/devices would require registration if your company manufactures/repacks/reprocesses/relabels, etc. them.  The only way ...