FDA considers all programming including that which tranfers into firmware/ROM, FPGA, etc. to be reviewable as software.
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Glen Emelock
Senior Partner
The CRO Group, Inc.
Melrose MA
United States
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Original Message:
Sent: 08-16-2011 19:14
From: Varda Swery
Subject: Design Controls - Software as a Medical Device
Is the code of a FPGA that is assembled into a medical device PCB has to be treated as 'software' according to FDA definition or can it be treated as part of hardware?
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Varda Swery
Signostics Ltd
Torrensville
Australia
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