Is IEC 60601-1-2 required by FDA for all electronic medical devices?

[milandy]

I have a question regarding a Class I electronic hardware device we’re currently developing. We asked a reputable lab to safety test it for us and they sent back a quote specifying IEC 60601-1-2 and FCC CFR 47 Part 15, Subpart B. The timeline they gave us for the IEC 60601-1-2 was not what our CEO was expecting, so he asked the lab – without talking to his QA/RA guy (me) – what was the minimum we needed to put the product in the hospital. The lab said just the FCC testing. They inferred that IEC 60601-1-2 was something the hospital expected, but that we were OK with FDA not getting the IEC 60601-1-2 testing done.

Does this sound right?

 

[Peter Selvey]

Strictly speaking, yes. In the US medical device regulations, for the most part standards don't exist in the law, they are there to help smooth the FDA's clearance for sale process such as a 510(k). If your device does not need to go through pre-market clearance then technically standards are not relevant. However if you do need a 510(k) then FDA will expect to see IEC 60601-1-2, or at least will require a good explanation if not applied.