IEC 60601-1 , 3rd edition and the FDA - Special 510k to my updated Medical Device

D

dmurali

#11
Re: IEC 60601-1 , 3rd edition and the FDA

I noticed this yesterday and was very confused about it too. I was not quite sure how to interpret it- If it meant both 3.0 and 3.1 or just 3.1. I have asked this question to our regulatory department who is going to reach out to FDA.

If anyone else has any other information, please share.
 
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thelastdon99

Starting to get Involved
#12
Re: IEC 60601-1 , 3rd edition and the FDA

Is there any update on this? I agree with Sab76, it is insane for the FDA to require compliance to amendment 1 on such short notice, without labs even certifying to it yet. Most test houses are just getting the hang of ed 3.0... Earth to the FDA, if you keep making policy changes like this you are going to put industry out of business and you out of a job.

Frankly, I'm sick of the over regulation. Yes, it keeps me employed but it is utterly disgusting how the government is operating, and if it doesn't come back to reality soon nobody is going to be able to sell anything. It is stifling the economy and especially small medical device firms that have to jump through these hoops that don't make a medical device any safer or more effective. Enough is enough FDA/US Government. You are grinding medical device innovations to a screeching halt.

Sorry for the rant, but this just grinds my gears.
 
U

usability

#13
Re: IEC 60601-1 , 3rd edition and the FDA

The federal register was issued on 1/14/2014.
Ed 3.0 was recognized on recognition number 5-78.
See attached.
The transition period of Ed 3.0 was indicated for CT and MRI.
Please confirm the recognized standards database of FDA HP.
Regards,
 

Attachments

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T

tallu

#16
Re: IEC 60601-1 , 3rd edition and the FDA

Is there any other guidance which is more specific?

Or does any one have good reference document for content of Special 510k?
 
G

gramaley

#18
Re: IEC 60601-1 , 3rd edition and the FDA

I was forwarded an email from personnel at the US FDA that indicates you don't have to retest to the 3rd edition if your product is certified to the 2nd edition, as "standards are voluntary". The company was told they could provide an explanation of the differences between the 3rd and 2nd edition, and they would accept that.

There are alternatives to using a gap analysis for some things, and a recent article in Qualit Digest by a Notified Body auditor explains how this can be done, without retesting to 3rd edition. I wonder if FDA would allow this too.

http://www.qualitydigest.com/inside/fda-compliance-article/your-medical-device-state-art.html
 

Ronen E

Problem Solver
Staff member
Moderator
#19
Re: IEC 60601-1 , 3rd edition and the FDA

Are you sure that it's the link you intended to post?

BTW, "an email from personnel at the FDA" is not something we can go by, IMO. What sort of personnel? Senior? Junior? Either way, FDA as an organization would most likely deny such correspondence, if confronted on such basis, saying that this is not official FDA stance but merely that individual's opinion. At most, it is applicable in the specific context in which it was issued. When it will become guidance or similar there will be a point in projecting to other cases. just MHO.

Ronen.
 
G

gramaley

#20
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.
 
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