• Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices : Final Guidance

Podcast on Standards & FDA’s Release of these Guidance Documents

FDA’s Captain Scott Colburn and Leo Eisner of Eisner Safety Consultants did a podcast with Jon Speer of Greenlight Guru on Standards Development of the IEC 60601 Series and these recently released Guidance documents. Listen to this conversation…

Some of items of note with the Final FDA Guidance include:

• FDA can now Recognize a standard and place on the Recognized Consensus Standards db prior to a formal Federal Register updates
• Declaration of Conformity (DOC) to follow requirements of ISO 17050-1 or as specified in the Final Guidance in section IV. A. (1)
• DOC process different for Consensus Standards that are horizontal, process-oriented, or that include choices relating to test methods, test selection, or have guidelines that apply to a broad range of device types and safety issues then FDA recommends submitters follow ISO 17050-2 – Supplier’s DOC – Supporting Documentation per section IV. A. (2) of the Final Guidance

IEC 60601-1, edition 3.2 (draft) and it’s collateral standards (IEC 60601-1-XX) are being updated and Leo discusses why this is happening, the timing and some of the impacts on manufacturers and design houses in this podcast.

FDA Guidance Documents – Additional Information

The draft guidance will be open for public comments and suggestions for 60 days at https://www.regulations.gov under Docket Number: FDA-2018-D-2936.

The Appropriate Use of Voluntary Consensus Standards final guidance describes the appropriate use and documentation of consensus standards for premarket submissions and how FDA staff intends to rely on consensus standards during the review process. Appropriate use of voluntary consensus standards can reduce requests from FDA staff for additional information to address issue(s) the standard was intended to address.  This guidance provides further clarity and explanation about the regulatory framework, policies, and practices regarding the appropriate utilization of consensus standards for premarket submissions.:”

Webinar about the Appropriate Use Final Guidance:

FDA will be hosting a Webinar on Thursday, October 25th, 2018. The webinar will be for manufacturers & others interested in learning more about the Appropriate Use final guidance. No registration is required.

• Time: 1:00 – 2:00pm EST (To ensure you are connected, dial-in prior to the start of the webinar)
• To hear the presentation and ask questions:
  Dial: 800-475-0481, International Callers Dial: 1-517-308-9467; Conference Number: 8090070; Passcode: 2387655
• To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW8090070&p=2387655&t=c
• Following the webinar, a transcript, audio recording, and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

Need help sorting out the proper medical device standards that apply to your device submission for the US, Canada, EU or elsewhere? Contact Leo “the IEC 60601 Guy” Eisner to help you thru this process at Leo at EisnerSafety dot com or schedule a call with Leo.

View all the articles I have written for InCompliance Magazine.

I hope you enjoy this article and if you have any questions please feel free to contact me at Leo at EisnerSafety dot com or schedule a call with me.

From what I have determined the change in transition date is based on that OSHA’s NRTL (Nationally Recognized Test Laboratories) Program will be aligning with the FDA in terms of this standard and will hopefully be by the end of this year, if not sooner, they will be able to approve NRTL Test Labs to the US National Version of IEC 60601-1, 3^rd ed. which probably will be ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text).  FDA has been intending to, and I hope they do, come out with a guidance document for premarket submissions of medical electrical equipment and what their expectations are for applying the US National Version of IEC 60601-1, 3^rd edition.  Also, about 1-1/2 months ago FDA announced their concern about cyber-security for medical devices and hospital networks and so they issued a Safety Communication on June 13, 2013 to medical device manufacturers, hospitals, medical device user facilities, health care IT & procurements staff; & biomedical engineers; and they issued a draft guidance document on the issue on June 14, 2013.  To coordinate all these activities, draft guidance documents, and agencies FDA decided to extend the transition period for the US National version of IEC 60601-1, 3^rd ed. equivalent.

The IEC 60601 series of standards that FDA has Listed in the Recognized Consensus Standards Listing and some of the ISO 80601 series of standards that FDA has listed are updated in List 031 with this new transition date, unless it is a brand new standard being published on the List for the first time, along with other changes that were ready to be published.  The Cyber-security standards are listed in Recognition List 032 and are all new listings to the List of Recognized Consensus Standards.  There were many other changes with these Recognition Lists 031 & 032 which will officially be published in the Federal Register as of 6 August 2013 and the changes will officially be effective then but have already been issued prior to August 6, 2013 in the FDA’s Recognized Consensus Database. (Either one or two days prior).

Below is a summary of the more critical changes, from my perspective, for List 031.

New Standards Added to the FDA’s Recognition List 031 (Table 2 of List 031) of significance are:

There were also modifications to the List of Recognized Stds (Table 1 of List 031) of some importance.  The 60601 related standards were updated to align with the transition period of ANSI/AAMI ES60601-1 std along with other changes of importance as noted below.

In a future blog post we may discuss Recognition List 032 and the Cyber-security standards.

If you have any questions or if you would like our assistance with regard to these standards please feel free to contact us at Leo@EisnerSafety.com.

In Addition to this article I have blogged on the topic a couple other times so if you want to see more material (original post) on the topic please continue to read on more of the details and experiences that impact many different people in many different ways (some good and some not so good) on the use of Medical Devices in the Home Use environment and how that impacts the users and their families that use these old and new technologies in the home.  Sometime these devices really are only designed for the hospital setting like some IV pumps, patients may have trouble with them to the point that patients pass away, which is a real tragedy no matter how you look at it.  There are 2 MD&DI articles on the Home Use Draft Guidance and one of the articles deals with an IV pump that probably shouldn’t have been in the home use environment with really sad results.

If you company needs support dealing with the IEC 60601-1-11 standard for Home Use Environment or with the FDA Home Use Draft Guidance document, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval we can provide you with regulatory, product safety, standards compliance, quality system services and more.  Please feel free to contact us at Leo@EisnerSafetty.com or 503-244-6151.   

The end of the transition period for 2^nd ed. of IEC 60601-1 is June 30, 2013.  By July 1, 2013 I hope you will be using the 3^rd ed. based standard for your FDA premarket submissions declarations of conformity.  Are you ready for this transition period and where is the transition information located?

The answer is that the IEC version of 60601-1 isn’t a Recognized Consensus standard after the end of the transition period for 2^nd ed. of IEC 60601-1.  FDA will allow the 2nd ed. of IEC 60601-1:1988 + A1: 1991 + A2:95 (Recognition Number 5-4, Recognition List #013) up til the end of the transition period of June 30, 2013 but the transition period isn’t noted in this entry of the Recognized Consensus Standards list.  So, where do you suppose it is located?  One could search for a very long time and not come up with the answer, as the FDA database for Recognized Consensus Standards is not flexible when it comes to search terms.  You need to know to search for the US national version of the standard, which is the AAMI ES version.  Also, the entries for the 3^rd ed based US national version of IEC 60601-1 vs. the 3^rd ed. + A1 national version of IEC 60601-1 aren’t in the database the same way.  One is in the database as ‘ES60601-1’ and the other is ‘ES 60601-1’.

So, as of now you can start to use the ANSI/AAMI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012, including the A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment – Part 1: General requirements for basic safety and essential performance [Recognition Number 5-71, Recognition List #029] OR ANSI/AAMI ES 60601-1:2005/A1:2012 [Recognition Number 5-74, Recognition List #030] Recognition list #030 was issued on 15 Jan ’13.  Up to and thru June 30, 2013 you can also use the 2^nd ed. of IEC 60601-1 [Recognition Number 5-4, Recognition List #013].  In the Extent of Recognition section of both ES 60601-1 standards you will find a sub-section titled “Transition:” which states:

“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.”
Note, the text of the transition for both of the ES 60601-1 standards is the same.

If you company needs support dealing with the IEC 60601 series of standards, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval we can provide you with regulatory, product safety, standards compliance, quality system services and more.  Please feel free to contact us at Leo@EisnerSafetty.com or 503-244-6151.   

On 15 Jan ’13 the FDA issued a notice in Federal Register for the Recognition List # 30.  The notice in the Federal Register said: “FDA maintains the Agency’s current list of FDA recognized consensus standards in a searchable database…FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.”

Other resources that you can find out more about this subject:

RAPS Regulatory Focus article of 15 Jan 2013

CDRH’s Standards Program / Standards Management Staff webpage

 On 24 Jan ’13 the Official Journal of the European Union published updated lists of Harmonized Standards under their respective Directives for the:

MDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*

AIMDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*

IVDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*

* – All of the consolidated lists of Harmonized Standards have a note that indicate that these are for reference only and are not the legal documents.  A repeat of the note for these Directives is below:

“The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS (Harmonised standards) database. This IT application HAS automates the process of the publication of the references of harmonised standards in the Official Journal of the European Union. Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal affect.”

Buyer Beware – Nursing Home Use Issue:

The FDA draft guidance says that the Home Use environment doesn’t include the use of a medical device in a “professional healthcare facility” (a defined term in the draft guidance) setting as noted in the definition for a “home use device”.  So, that means if you have a device that is designed only for use in a nursing home environment (a “professional healthcare facility” setting per the FDA’s interpretation) that the FDA won’t consider it to fall under the FDA’s draft guidance document and therefore under IEC 60601-1-11:2010 (1st ed.) which is the standard the FDA draft guidance document mentions exclusively, in terms of medical electrical equipment home use device standard.

I noted that the AAMI version of IEC 60601-1-11 standard which is titled “ANSI/AAMI HA60601-1-11:2011 (IEC 60601-1-11:2010, MOD)” has some US national deviations.  The National Deviation of import is that note 2 of the definition for “Home Healthcare Environment” (sub-clause 3.2) has been changed from saying that a nursing home is considered to be the “Home Healthcare Environment” to be a “professional healthcare facility”.   This spurred me to check the FDA’s List of Recognized Consensus Standards and the standard the FDA has Recognized for this issue is the IEC 60601-1-11:2010 version of the standard and not the AAMI version.  In the FDA’s Recognition it states “While this standard (IEC 60601-1-11:2010) recognizes long term care facilities as home use environment, FDA does not consider long term care facilities to be home use environment.”  This surprised me, somewhat, as the AAMI standard has the exception specifically stated right in the US National Deviations and the FDA’s lead for the Home Healthcare Initiative Mary Brady is one of the two co-chairs for the AAMI version of the standard.  Meaning it is clear to me that the FDA was well aware of the national deviation that ended up in the US National standard ANSI/AAMI HA60601-1-11 whereas it is not in the IEC version of the standard and never could be as it is an international standard and therefore national deviations are not allowed. This implies to me that the FDA made a mistake (dare I say such a thing) and should have referenced the AAMI HA60601-1-11:2011 standard instead of the IEC 60601-1-11:2010 standard in the FDA draft guidance and as the US National Recognized Consensus Standard.

So the current bottom line is this (remember it is a draft guidance so it may change):  If you have a device intended only for the nursing home environment and you go to a Safety Agency (i.e. UL, CSA, Intertek, TÜV SÜD, etc.) for a Safety Certification Mark you may be forced into the Home Use standard under IEC 60601-1-11:2010 unless you point out to the Safety Test House that there is a US deviation under the AAMI version (AAMI HA60601-1-11:2011) which says that Nursing Home Equipment is a professional use device which means the standard wouldn’t apply.  That is only if you are going for the US market only.  If you also want the EU or Canada or another country it is likely you may end up needing to get a Safety Agency Mark to IEC 60601-1-11:2010.  If you do get the Nursing Home Use device Safety Agency certified to IEC 60601-1-11:2010 and you go to the FDA for a pre-market submission (i.e. 510(k)) with this as part of your market clearance test data and you use the FDA draft guidance for home use, as well, you may run into some trouble because now the FDA may say this isn’t a Home Use Device per the draft guidance and so they may ask a lot of questions or they could ask you to rethink your approach and resubmit when you get things straight.

MD&DI Articles:

The two articles are “FDA’s Home Use Draft Guidance: Good But Not Gospel” and the really heat breaking story “How a Bad IV Pump Got into Nancy Stark’s Home”.  I hope these articles give you some perspective on the draft guidance document and I know I will be sending in a comment to the FDA in regard to the Home Use Draft Guidance based on the above “Buyer Beware – Nursing Home Use Issue” so hopefully the FDA can clarify this and make it clearer to the user of the Guidance document and that it links better to the applicable standard.

Related Articles:

FDA on Quest to Standardize Mandatory MedDvc Labeling

FDA Issues Draft Guidance on MedDvcs Intended for Home Use