FDA Product Safety Standard Deadline Looming – 60601-1 Edition 3, Amendment 1


FDA Product Safety Standard Deadline Looming – 60601-1 Edition 3, Amendment 1

July 30, 2016 marks the last day that the FDA will accept an Electronic Medical Device Product Safety submission based on IEC 60601-1, Edition 3 without  Amendment 1 (called Edition 3.1). This standard is shown in the Recognized Consensus Standards list as ANSI/AAMI ES 60601-1 (See http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=32316), with US Deviations and Amendment 1.

FDA’s official statement is this: “FDA recognition of ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 [Rec# 19-5] will be superseded by recognition of ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 [Rec# 19-4]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 19-5] until August 1, 2016. After this transition period, declarations of conformity to [Rec# 19-5] will not be accepted.”

This means that if you are preparing a submission to the FDA for a medical electrical device that will arrive after July 30th, your documentation and evidence of compliance to the 60601-1 standard must include Amendment 1. This is applicable for FDA 510(k) and PMA device submissions, and re-submission due to a device change, per the FDA 510(k) Memorandum #K97-1. Previously cleared (510(k)) or approved (PMA) devices that were submitted under 60601-1 Edition 3 without Amendment 1 are grandfathered.

In general, Amendment 1 includes:

Changes to Risk Management requirements
Changes to essential performance and examples of essential performance
Changes to test requirements
Addresses labeling changes, including changes to electronic labeling requirements

See prior blog entry <insert link here> for 60601-1 Edition 3, Amendment 1 specifics.

The Realtime Group has deep Medical Product Development experience, including standards compliance, including IEC 60601-1.  We have a shared passion for time to market and product compliance. Visit us at www.TheRealtimeGroup.com or call us at 972-985-9100 to see how we can help you with your product development and testing!