Hello Rania,
You will not find anything specific about labelling of Software as a Medical Device (SaMD) though as you state there is some information on UDI. Having made 510(k) submissions in the past, usually in Section 13 - Labelling, we provided content of the About or Information pull-down where it would have the information related to identity of product, version level, manufacturer, contact information, etc., the typical things you would imagine on a physical label. And you are correct there are some things which are related specifically to SaMD which would not be a medical device like using the version level instead of a lot/serial number. There is just so much information for a SaMD which is not relevant which you would find for a physical product like expiration date, sterility, materials, kit components, and so forth; the content of the "label" in the About information is usually fairly straightforward. Those items from a UDI perspective would just not be applicable. Just one caution, the Instructions for Use (IFU) of an SaMD is something integrated into the application itself and there is not a concise IFU or something which could be printed. I have had in the past reviewers want an IFU, so we had to extract information from the screens and menus to create an IFU. This does depend on the reviewer, though if you do not already have a singular IFU something to be aware.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 06-Jun-2022 15:38
From: Rania deLeon
Subject: Stand alone software labeling
I am preparing a 510k for a software as a medical device and wondering what are the labeling requirements? I know I have to provide the UDI through either or both of the following:
(1) An easily readable plain-text statement displayed whenever the software is started;
(2) An easily readable plain-text statement displayed through a menu command (e.g., an "About * * *" command).
Are there any other labeling requirements besides UDI for SaMD? For example, for other devices I have experience with we provide a label with model number, device diagram, device specifications (OD, ID, length etc...). Do I need to make something similar for my SaMD or do these not really apply? Also, for UDI, I assume I need to register with GSI and get the company prefix and my UDI would include the following:
the AI 01, the GS1 company prefix, the device indicator, the check digit, the AI 17, expiration date (doesn't really apply to SaMD?), AI 11, manufacturing date (I guess I can apply the version release date?), AI 10, and lot number (I guess this can be the version number?).
Thanks in advance for the help!
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Rania deLeon
QA & RA Manager
Morton PA
United States
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