Re: IEC 60601-1 , 3rd edition and the FDA
I certainly understand your point. The person that sent the email to me explained to FDA that they thought the standards were voluntary, and the FDA has ALWAYS agreed tha this is the case. Getting a 510(k) without using them is problematic, so it was interesting to read this email response from FDA
Here is an unedited version of the email from an FDA Physicist Robert Sauer, after Mr. Sauer checked internally and responded back to the consultant.
Sorry for the delay, I had to ask around a bit to find an answer. I?ve checked with our standards expert here and if you deviate from a standard, for example, by conforming to one edition instead of the currently recognized one, you should:
a) Provide the full test report for the standard to which your device does conform, and
b) Provide a detailed analysis of the differences between the version to which your device conforms, and the version that is currently FDA recognized, and explain why the alternate version still provides an equivalent assurance of safety and effectiveness.
This is very much akin to the European "Gap Analysis" perspective. I know that FDA met with experts in standards this last year in Europe, and there was a lot of this "standards are voluntary, but you need to do a gap analysis to them to meet the "state of the art". The article in Quality Digest "Is your medical device State of the art" certainly challenges the idea that you should always have to do a gap analysis. Seeing this from an experienced Notified Body auditor was especially refreshing.