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

#1
Hi all,

Last year I submitted a 510k to an electronic medical device which was approved based on safety tests which were made according to 60601-1 2nd edition.
I am planning to submit a special 510k to my updated device (updated SW and updated EMC protection) , do I need at any case to resume the safety tests according to 60601-1 3rd edition?
Thanks
Nissim
 
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Ronen E

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

FDA recognition of Edition 2:1988 (A1:1991+A2:1995) of IEC 60601-1 is hereby superseded by recognition of ANSI/AAMI ES60601-1:2005, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance. FDA will accept declarations of conformity, in support of premarket submissions, to Edition 2:1988 (A1:1991+A2:1995) of IEC 60601-1 until June 30, 2013. After this transitional period, declarations of conformity to Edition 2:1988(A1:1991+A2:1995) of the standard will not be accepted.
Refer http://www.accessdata.fda.gov/scrip.../detail.cfm?standard__identification_no=30270

FDA recognition of Edition 2 of ANSI/AAMI/IEC 60601-1-2 is hereby superseded by recognition of Edition 2:2001 together with Amendment 1:2004. FDA will accept declarations of conformity, in support of premarket submissions, to ANSI/AAMI/IEC 60601-1-2:2001 with or without Amendment 1:2004 until March 1, 2009. After this transitional period, declarations of conformity to Edition 2:2001 of the standard without Amendment 1:2004 will not be accepted.
Refer http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/Detail.cfm?ID=21611

If you manage to submit your special 510(k) by June 30, you can completely rely on testing according to the 2nd edition family. After that date (as much as I understand), all test results submitted in a 510(k) must be to the 3rd edition, unless they only relate to specific parts for which other transnational arrangements have been published by FDA.
 
U

usability

#4
Re: IEC 60601-1 , 3rd edition and the FDA

The transition date will be extended to December 31, 2013.
 
U

usability

#6
Re: IEC 60601-1 , 3rd edition and the FDA

The following information(extract) was issued to the members of MITA.

FDA/CDRH Extending Transition Date for the ANSI/AAMI ES60601-1 and Relevant Recognized Standards
June 13, 2013
In order to assist in the coordination efforts with other US Federal Agencies and Departments, such as OSHA, using the ANSI/AAMI ES60601-1(3rd edition) and relevant standards, FDA/CDRH has decided to modify the transition language for these standards, extending the current date of transition from June 30th to December 31st, 2013 as follows:
?FDA recognition of the 2nd Edition of the IEC 60601-1, including its relevant recognized collateral and particular standards, will be superseded by way of the ANSI/AAMI ES60601-1:2005 (3rd edition), including all its existing amendments and relevant recognized collateral and particular standards in this series. However, FDA/CDRH will continue to accept declarations of conformity, in support of premarket submissions, to the 2nd Edition of relevant standards in the IEC 60601 series until December 31, 2013. After this transitional period, declarations of conformity to those standards will no longer be accepted.?
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: IEC 60601-1 , 3rd edition and the FDA

:thanx:

When did MITA receive it from the FDA? I can't seem to find any similar indication on the FDA's website. :confused:
 
U

usability

#8
Re: IEC 60601-1 , 3rd edition and the FDA

The member of MITA received this information on June 19, 2013.
I hope the transition date is extended in FDA web site by June 30, 2013.
 
U

usability

#9
Re: IEC 60601-1 , 3rd edition and the FDA

The federal register was issued on August 6, 2013.
See attached.

Best regards,
 

Attachments

S

sab76

#10
Re: IEC 60601-1 , 3rd edition and the FDA

Did anyone else notice that the FDA completely blew by compliance to Edition 3.0 and instead opted for Edition 3.1? The callout in the Federal Register was for ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010(R)2012 (Consolidated Text).

This is completely insane as nobody is even certifying to Edition 3.1 yet. Worse yet, why is no one raising a fuss about it?

Does anyone have any insight?
 
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