ISO 15197:2013 (Blood glucose monitoring system) was released in May

#1
ISO 15197:2013 (Blood glucose monitoring system) was released last month!!!

Does anyone know that:
(1) When will this version of standard comes into force in FDA?
(2) And, after this standard coming into force, can we keep selling the product which has been imported into US before that date?

Many thanks!
 
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Mikishots

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#2
Re: ISO 15197:2013 (Blood glucose monitoring system) was released in May!!!

The 2003 version is officially withdrawn and the 2013 version is officially published. The FDA would be expected to be using the only released, published version, particularly because they've been the most vocal about how badly the 2003 version sucked. However, as of the end of May, they've yet to adopt it. Only after harmonization of the ISO standard in a DIN EN ISO standard, with a transitional period of three years, is the new DIN EN ISO standard binding. I've read in some sources that the target right now for the FDA is September.
 

Ronen E

Problem Solver
Staff member
Moderator
#3

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#4
Re: ISO 15197:2013 (Blood glucose monitoring system) was released in May!!!

It is really weird! Cannot find any clue on FDA website what is their reaction to the new version of ISO15197, which seems revised mostly base on FDA's opinion...

So, (Mikishots) do you mean normally an ISO standard will become effective in FDA after DIN EN ISO standard release?
 

Mikishots

Trusted Information Resource
#5
Re: ISO 15197:2013 (Blood glucose monitoring system) was released in May!!!

It is really weird! Cannot find any clue on FDA website what is their reaction to the new version of ISO15197, which seems revised mostly base on FDA's opinion...

So, (Mikishots) do you mean normally an ISO standard will become effective in FDA after DIN EN ISO standard release?
No. This is the situation for this particular topic we're discussing. I won't venture to make high level encompassing statements...

I suppose they're taking their time and looking at it more closely to see that it really will address the issues they're concerned about; when the squeaky wheel gets the grease and then complains about the grease, that's not good.
 

Ajit Basrur

Staff member
Admin
#6
Re: ISO 15197:2013 (Blood glucose monitoring system) was released in May!!!

It is really weird! Cannot find any clue on FDA website what is their reaction to the new version of ISO15197, which seems revised mostly base on FDA's opinion...

So, (Mikishots) do you mean normally an ISO standard will become effective in FDA after DIN EN ISO standard release?
Paul,

Not a concern there ... you should be continuing to use the new version as ISO 15197 is one of the Recognized Consensus Standards and the last update on the respective page was done on Jan 15, 2013. It may appear on the next update.

http://www.accessdata.fda.gov/scrip.../detail.cfm?standard__identification_no=12109

Since FDA recognizes the ISO standard as the principal one, you are mandated to use the cirrent revision of the ISO 15197.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: ISO 15197:2013 (Blood glucose monitoring system) was released in May!!!

As of 1 July 2013, the NBW ProCode webpage still relates to the 2003 issue.

What's even more strange is that the same page relates to a FDA guidance document that was withdrawn in 2011: http: //www. fda. gov/ medicaldevices/deviceregulationandguidance/guidancedocuments/ucm079138.htm - DEAD LINK
 

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#8
Hi Ronen,
The withdrawed guidance is for "invasive" BGMS. But, ISO 15197 is actually for in vitro self-testing BGMS (basically this category is non-invasive). So, the withdrawed guidance is actually unrelated to ISO 15197. But, thank you for the information anyway. Cheers!
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Hi Ronen,
The withdrawed guidance is for "invasive" BGMS. But, ISO 15197 is actually for in vitro self-testing BGMS (basically this category is non-invasive). So, the withdrawed guidance is actually unrelated to ISO 15197. But, thank you for the information anyway. Cheers!
Yes, I meant these as 2 separate issues. I couldn't understand what's the point in referring to a document that the agency doesn't back any more.

Cheers.
 
M

missjenny

#10
Hello,

Is it possible for manufacturers to obtain CE Certificate with ISO 15197:2013 as the standard rather than 2003 right now? I know that the 2013 standard is not mandatory, but I want to know if it is possible to get a blood glucose meter certified using the 2013 standard.

Thank you.
 
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