That’s a really good question and the answer is sooner than I would have thought. Especially since the draft guidance has been pushed forward and then pushed back aside so many times internally at FDA it is really hard to know if this time it will truly happen or not. I would hazard to guess in the 1st or 2nd quarter of 2014 we should hopefully see a draft guidance document come out of FDA on AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. The AAMI document is equivalent to the US National version of IEC 60601-1:2005 + Amendment 1:2012 (the IEC standard plus a page or so of US National Deviations). But I have heard rumor of release predictions multiple times for over 5 years. None of the predictions so far have come true so one can only hope this will change because of internal pressures within FDA & some external pressures too. The pressures that seem to be making this more urgent within the FDA are:
1) When the FDA extended the transition period for the Recognized Consensus Standard IEC 60601-1:2005 + A1:2012 (US National Version) from June 30, 2013 to the end of this year to Dec 31, 2013. They did so FDA could align with the OSHA NRTL program (Nationally Recognized Test Lab program – a program where OSHA authorizes certain test labs for specific test standards to issue a Safety Agency Mark under the NRTL program) for this standard. Some time in May ’13 OSHA finally relaxed their opposition to the use of the US National Version of IEC 60601-1, 3rd ed., but this has not been publicly announced yet. In the last couple months OSHA has been planning to announce that they would start to authorize a couple test labs under the US national version of IEC 60601-1:2005 + A1:2012 before the end of this year. But OSHA hasn’t publicly announced, via the Federal Register, it’s intentions yet. It is known throughout industry that OSHA plans on authorizing test labs to the AAMI version of IEC 60601-1:2005 (3rd ed.) + A1:2012 specifically with A1 incorporated with 3rd ed. OSHA believes that 3rd ed. doesn’t meet the requirements of the NRTL law as the manufacturer is considered involved in the testing of the device since the manufacturer puts the Risk Management File together for the test lab to review which contradicts what the NRTL law allows. Per the law the test lab has to conduct all the testing. For some reason OSHA is ok with the US version of IEC 60601-1:2005 + A1:2012 and doesn’t believe it violates the law so they are planning to announce starting the authorization process of a few test labs to authorize them under the 60601-1:2005 + A1:2012 (US version) by the end of the year. Even if the announcement happens shortly it is unlikely OSHA will be able to authorize 1 or more labs by the end of the year. Will FDA need to extend the transition period again or will they want to again? That is a big question we will have to wait and see what happens.
2) On June 14, 2013 FDA released a draft guidance document for the Management of Cybersecurity in Medical Devices. FDA decided the 60601-1 guidance should also consider the Cybersecutiry Guidance document as 60601-1 is about medical electrical equipment which means most of these types of devices would be impacted to some degree by cybersecurity issues.
3) Lastly, FDA is working with NIST to try and align Conformity Assessment programs for 60601-1 testing so that the EU & the USA can harmonize this process. This is based on a USA EU Free Trade Agreement that has spurred this process on.
What are some of the issues the draft guidance will cover? The guidance will most likely include how the FDA will view and expect the manufacturer to deal with the Risk Management File requirements of 3rd ed. + A1 of 60601-1, the FDA draft guidance on Cybersecurity, and now that A1 was published back in Aug of 2012 FDA they will want to consider any changes that impacts the guidance document as FDA will only be accepting 3rd ed. + A1 after Dec 31, 2013. These are the things that I have knowledge of and I am sure I could speculate more but won’t for now as this document has been such a moving target for so long.
You may be interested in another blog post I have written related to these issues:
If you need any support with FDA and the AAMI ES 60601-1 standard we would be happy to assist you. Let us know what we can do to help your company be successful in this transition with FDA. Contact Leo Eisner by e-mail or call us at 503-244-6151.