Regulatory Open Forum

Situation: Medical SW runs on a standard cell phone. The OS (Operating System) of the cell phone is Windows Mobile. A new cell phone is now used for the medical SW, and the phone has an Android OS.

FDA says that a Letter to File cannot be used when there is a change to the "operating principle."
A change to the OS is not a change to the operating principle, but is a major SW change, which will probably require a new 510(k).

Question: is a Special 510(k) appropriate for such a change (to the OS); of course, the intended use, etc. remain the same and all the other conditions for a Special 510(k) are fulfilled.

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Asher Kassel
Lifewatch Technologies Ltd.
Rehovot
Israel
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Hi Asher,

A Special 510(k) would be required as the change in the OS does not affect the intended use of the device nor alter the fundamental scientific technology of the device.

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Lori Kahler
Director Regulatory and Compliance
Samsung Electronics America, Inc.
Ridgefield Park NJ
United States
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Original Message:
Sent: 06-24-2014 02:05
From: Asher Kassel
Subject: Change in OS - Special or Traditional 510(k)

Situation: Medical SW runs on a standard cell phone. The OS (Operating System) of the cell phone is Windows Mobile. A new cell phone is now used for the medical SW, and the phone has an Android OS.

FDA says that a Letter to File cannot be used when there is a change to the "operating principle."
A change to the OS is not a change to the operating principle, but is a major SW change, which will probably require a new 510(k).

Question: is a Special 510(k) appropriate for such a change (to the OS); of course, the intended use, etc. remain the same and all the other conditions for a Special 510(k) are fulfilled.

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Asher Kassel
Lifewatch Technologies Ltd.
Rehovot
Israel
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This is covered in the K97-1 Memorandum (still active), Deciding When to Submit a 510(k) for a Change to an txiating Device​, under Technology Engineering, and Performance Changes, B8, starting on p14.  Based on what I've seen in the past, I believe this would be a Traditional.  Should you choose to submit as a Special, there may be a high likelihood of coversion to a Traditional, which may slow the clock down.  Depending on where you are in the development process, you may always ask FDA via a pre-submission meeting teleconference (reference thr following Guidance Document: The Pre-Submission Program and Meetings with Food and Drug Administration Staff).  

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Julia Nelson RAC
Principal Regulatory Affairs Specialist
Medtronic Cardiovascular
Moundsview MN
United States
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Original Message:
Sent: 06-24-2014 02:05
From: Asher Kassel
Subject: Change in OS - Special or Traditional 510(k)

Situation: Medical SW runs on a standard cell phone. The OS (Operating System) of the cell phone is Windows Mobile. A new cell phone is now used for the medical SW, and the phone has an Android OS.

FDA says that a Letter to File cannot be used when there is a change to the "operating principle."
A change to the OS is not a change to the operating principle, but is a major SW change, which will probably require a new 510(k).

Question: is a Special 510(k) appropriate for such a change (to the OS); of course, the intended use, etc. remain the same and all the other conditions for a Special 510(k) are fulfilled.

-------------------------------------------
Asher Kassel
Lifewatch Technologies Ltd.
Rehovot
Israel
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