Let’s start with some really big news!!!

It is anticipated in 2019 IEC 60601-1 edition 3 + Amendment 2 will be published & around 2024 we anticipate that 4th ed. of IEC 60601-1 will be published.

If you want more details about what is happening with the IEC 60601-1 changes so you can plan for these big changes consider our Standards Annual Reports on the Medical Electrical Equipment Standards and/or Home Use Medical Electrical Equipment Standards which goes over what is happening with draft and newly released standards and technical reports.

We are offering a “Special April 2016 Flash Sale” on the Standards Annual Reports discount for new customers and a super deep deep discount pricing for our loyal customers

We have broken this post into national areas

• USA FDA
• EU MDR & RoHS-2
• IMDRF Update
• Brazil
• China CFDA & China RoHS-2
• Russia
• Home Health Care Articles
• Standards Update
  • So much is going on with ISO 13485:2016 (links to details below) – “Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes”.   Also, we keep adding to the post on ISO 13485:2016 is Now Available – Start Planning Your Transition.  Come and find all the great resources we link you with and also read the post to learn the steps to start your transition planning..
• New Strategic Services to help your Company in 2016 & into the future
  • Strategic Reports on Future Development of Standards that impact your Medical Devices – Flash Sale for April 216 – this service helps you strategize your product development process to know in advance when changes to standards may impact your devices and save you a lot of money in the long run.  A great example is will you be ready for the major changes that IEC 60601-1-2, 4th ed. will place on your products?  What is going on with changes in process for IEC 60601-1 3rd ed. + Amendment 2 and the future 4th ed.?

  • BIG PRICE DROP ON OUR

    Standards Reconnaissance Database – this service helps you maintain your list of standards, be up to date on current and new /developing standards.  Also, get strategic information about the future of these current, new and developing standards.  Save time and money using this service that would take you many more hours than the cost of this service to keep up to date on these standards.

Now only $900/yr for our Base subscription level or $1650/yr for a Full subscription level.  These are sale prices so get them while they last.  We have updated our service to make it more affordable but with the same information except we removed the annual report.  You get a better annual report in the above service that is much more detailed than we were offering with our db.

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USA
FDA – Are you aware of the many issues with  FDA? Here are some of the relevant issues to keep up on

1) FDA Device Regulations, a few of which are coming later in 2016.  The FDA has a transparency initiative known as the Transparency Results Accountability Credibility Knowledge Sharing (TRACK).  The database shows what is expected for upcoming proposed and final rule making.  A couple of the items on that list are noted here. The dates in the db don’t guarantee the release of those rules. More information on the process the FDA follows to issue Rules & Regulations.

a) Use of Symbols in Labeling

Abstract “The purpose of this rule is to allow for the inclusion in device labeling of stand-alone symbols established as part of a standard developed by a national or international standards development organization, provided that such symbols are explained in a symbols glossary that is included in the labeling for the medical device. The rule also revises prescription device labeling regulations to authorize the use of the symbol statement “Rx only” on the labeling of prescription devices.”  One of the standards referenced is AAMI/ANSI/ ISO 15223–1:2012, Medical Devices— Symbols to be Used With Medical Device Labels, Labeling and Information to be Supplied, Part 1, General Requirements. The proposed rule announcement was published in the Federal Register on April 19, 2013.  The final rule is scheduled for March 2016 but as mentioned above the dates may not always be met.

b) Declaration of Labeling for Home-Use Devices

Abstract: “The purpose of the proposed rule is to require certain medical device establishments listing home-use medical devices to submit, in electronic format, the label and package insert of such certain medical devices listed with FDA. FDA intends to make the information from the submitted labeling accessible by the public through a focused Internet site.”  This is in the proposed rule stage and is expected to be issued around May 2016 if on time.

c) Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System

Abstract: “The proposed rule would establish special controls for the computed tomography (CT) X-ray system. A CT X- ray system is a diagnostic X-ray imaging system intended to produce cross-sectional images of the body through use of a computer to reconstruct an image from the same axial plane taken at different angles. High doses of ionizing radiation can cause acute (deterministic) effects such as burns, reddening of the skin, cataracts, hair loss, sterility, and, in extremely high doses, radiation poisoning. The design of a CT X-ray system should balance the benefits of the device (i.e., the ability of the device to produce a diagnostic quality image) with the known risks (e.g., exposure to ionizing radiation). FDA is establishing proposed special controls, which are necessary to provide reasonable assurance of the safety and effectiveness of a class II CT X-ray system.” This is in the proposed rule stage and is expected to be issued around July 2016 if on time.

2) FDA continues to issue lots of Draft & Final Guidances.  Here are some relevant ones since our last update in Jan 2016:

a) Draft Guidance (Issued on January 26, 2016) – Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff

b) Draft Guidance (Issued on February 3, 2016) – Applying Human Factors and Usability Engineering to Medical Devices – Guidance for Industry and Food and Drug Administration Staff

c) Draft Guidance (Issued on February 3, 2016) – Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

d) Draft Guidance (Issued on February 3, 2016) – Linked with Item 2)b) Guidance. This Guidance provides a List of the Highest Priority Devices for Human Factors Review per FDA.  As this is a draft Guidance this list is not final but one I would highly recommend you follow, if you are submitting a product that is on this list, for a regulatory approval thru the FDA. – List of Highest Priority Devices for Human Factors Review – Draft Guidance for Industry and Food and Drug Administration Staff

e) Draft Guidance (Issued on February 9, 2016) – Display Devices for Diagnostic Radiology – Draft Guidance for Industry and Food and Drug Administration Staff

f) Final Guidance (Issued on March 7, 2016, the draft of this document was issued on January 27, 2015) – Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails – Guidance for Industry and Food and Drug Administration Staff

g) Draft Guidance (Issued on March 7, 2016) – Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes – Draft Guidance for Industry and Food and Drug Administration Staff

h) Final Guidance (Issued on March 22, 2016, the draft of this document was issued on June 29, 2015) – Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices – Guidance for Industry and Food and Drug Administration Staff

3) FDA national evaluation system for medical devices announcement on 4 April 2016: “Establishing a national evaluation system for medical devices is one of CDRH’s 2016-2017 strategic priorities. A national evaluation system is a collaborative system that monitors, links, and analyzes real-world data from many different sources—including clinical registries, electronic health records and medical billing claims— across the medical device landscape with the goal of better understanding how medical devices perform. By harnessing such real-world data using state-of-the-art techniques, such a system will provide information that not only contributes to regulatory decisions, but also promotes device innovation, and importantly provides timely and meaningful information directly to patients and their physicians.

Today, as an outcome of a cooperative agreement with FDA1, the Duke-Margolis Center for Health Policy published its vision on a coordinating center for such a system. “Better Evidence on Medical Devices: A Coordinating Center for a 21st Century National Medical Device Evaluation System” describes expectations for a national evaluation system’s Coordinating Center (you may recall that the planning board called for a Coordinating Center in its February 2015, “Strengthening Patient Care: Building a National Postmarket Medical Device Surveillance System”). The Coordinating Center will guide the future development and implementation of a national system.

Today’s publication is an important step toward building a national evaluation system. For more information about a national evaluation system, please visit the FDA’s National Evaluation System webpage.”

4) FDA on 4 April 2016 published in the Federal Register their latest updates to the list of Recognized Consensus Standards with some new additions, some updates and some withdrawals.  This is List 041 as published in the Federal Register and has some important updates that include finally adding in the IEC 61010-1 Lab Equipment standard among many other changes.  As of April 5, 2016 the Recognized Standards database has not been updated with these new standards updates.

5) Updated FDA Web Page on “Interference between CT and Electronic Medical Devices“. Last Updated on 31 March 2016.

6) Updated FDA Web Page on “eMDR System Enhancements“. Last Updated on 31 March 2016.

Part of the Standards Reconnaissance Database Service will include a listing of current FDA CDRH Guidances Final & Draft plus we will be adding in the Canadian and Europe Guidances, as well. We will be launching this stage 2 in the next month or so. Learn more about this db.  If you would like a live demo of the db please contact me directly at Leo@EisnerSafety.com.

EU  

Updates on the Draft EU Medical Device and the In-Vitro Diagnostic Regulations

This is a moving target but there are some really good resources for updates on these draft Regulations and my favorite sources to find out info on this topic are Erik Vollebregt’s Blog called www.medicaldeviceslegal.com, the MedTech Europe website (MedTech Europe is an alliance of European medical technology industry associations. It currently has two members: EDMA, representing the European in vitro diagnostic industry; and Eucomed, representing the European medical devices industry), and BSI’s updated white paper on “The proposed EU regulations for medical and in vitro diagnostic devices: An Overview of the likely outcomes and consequences for the market” (You need to fill out a form to download the White Paper but it is totally worth it). Anything new with Erik’s & MedTech Europe’s sites of late:

1) On Erik’s site he has done a post titled “Medical devices M&A – data protection” and it focuses on data protection in the EU is a major issue that needs to be addressed seriously and hopefully early enough on in a company’s history so when you are at the Mergers and Acquisition stage you aren’t trying to gigger with it at this late date as it could devalue your sale of your company.
2) In our previous Global Update MedTech Europe wrote about Advocacy activities related to the MD & IVD Regulations. It also looks at the past and future work to be done.

EU RoHS-2 – Courtesy GreenSoft Technology, Inc.

The Bulk of RoHS-2 Exemptions Expire This July: Be Prepared!

Renewal Requests Submitted for Large Number of EU RoHS-2 Exemptions

IMDRF Update  

IMDRF Offers Progress Updates at March Meeting in Brazil – Excellent update by RAPS Regulatory Focus which discusses the various updates by the Regulators including on the Medical Device Single Audit Program (MDSAP) and it’s progress, presentations on the topic of Software as a Medical Device, and current work summary for IMDRF (See below listing).

Current IMDRF work items include:

1. Medical Device Single Audit Program (MDSAP)

2. National Competent Authority Report (NCAR)

3. Software as a Medical Device (SaMD): Clinical Evaluation

4. Regulated Product Submission (RPS)

5. Patient Registries

6. Adverse Event Terminology

7. Good Regulatory Review Practices – Competence and Training Requirements for Pre-market Reviewers and Product Specialist

 Brazil IEC 60601-1-9 required End of 2016 Are You Ready?

Refer to our recently released blog post dated 6 April 2016. 

China  

CFDA – (China Food & Drug Administration) – Articles Courtesy CIRS-MD

Summary of Medical Device Guidelines of 2015 in China – In order to standardize the supervision and strengthen the guidance of medical device registration, CFDA had conformed and released a series of Medical Device Guideline in 2015. These guidances will help you prepare your submission dossier and for registration evaluation. What to include inside Guideline? and What guidelines did CFDA release?

“Guideline for Medical Device Good Supply Practice On-site Inspection”Interpretation – In order to strengthen the supervision and management of medical device distribution, standardize and guide the Good Supply Practice (GSP’s) on-site inspection, CFDA has formulated the Guideline for Medical Device Good Supply Practice On-site Inspection, issued Oct.15th , 2015. How to deal with the on-site inspection, and what is the criteria of inspection result determining?

“Administration Regulations for Instruction and Label of Medical Device” Interpretation – CFDA has put Administration Regulations for Instruction and Label of Medical Device (click on the Documents tab to get the regulations text) into effect on 2014.10.01, and issued the interpretation of this regulation to help enterprises to have better understanding of this regulation on 2015.02.05. What are the requirements of medical device instruction and label and their content? what are the contents forbidden in the instructions and labels?

“Administrative Measures for Quality Supervision on the Use of Medical Devices” – On Oct 23th, 2015, China Food and Drug Administration (CFDA) has promulgated Administrative Measures for Quality Supervision on the Use of Medical Devices to strengthen the management of the use of medical devices. According to the regulation, medical device use parties shall set up appropriate quality management system, which includes two aspects: one involves purchase, acceptance check and storage; another one involves use, maintenance and transfer.

CFDA 2015 Medical Device Regulatory Data Analysis – CFDA has released the 2015 Food And Drug Regulatory Statistical Annual Report, which announced the objective data about health food, drug, medical device and cosmetic. The data involved with manufacture, distribution, registration, and so on. This article discusses medical device regulatory data from 2012 to 2015 which involved with the number of Medical Device Registration during 2011~2015, as well as medical device manufacturers and distributors.

Final China RoHS-2 Regulation Published – Courtesy GreenSoft Technology, Inc. 

Russia   

Recently I found an English version of the Roszdravnadzor* website (Federal Service for Surveillance in Healthcare).

*”Roszdravnadzor executes the state supervision over observance of the Russian Federation legislation regarding the state supervision over quality and safety of medical practice, compliance to the procedures of healthcare provision and the standards of medical care by institutions and individual medical practitioners.

Home Health Care Articles Courtesy of HomeCare magazine

The Homecare Technology Race

Keeping Seniors in Their Homes with Technology

The Future of Home Health

Standards Updates  

ISO 13485:2016 – Medical devices. Quality management systems. Requirements for regulatory purposes

This segment has been update since the Publication of the ISO 13485:2016 standard.

The standard has been published as an International Standard. It was published late February but the official date on the ISO version of the Standard is March 1, 2016.
A white paper  by the Working Group WG1 of the Technical Committee TC210 proposed that there be a three (3) year transition period.  From what I have seen this seems like it will be followed but I would recommend that you check with your Notified Body or Certification Body that you are using for your Quality System Certificate to ensure you are on the same time schedule they are.

The proposal from the white paper says:
This phase concerns the co-existence of the availability of accredited certification to ISO 13485:2003 and ISO 13485:2016. It is recommended to ISO TC 210 that this phase last for three years, during which time users will have to update their quality management systems to meet the requirements of ISO 13485:2016 to an accredited certificate. It is recommended that the users of ISO 13485:2003 work with their certification bodies or registrars to schedule an upgrade audit at a convenient time within the transition period.
It is recommended that:

Two years after the publication of ISO 13485:2016 all accredited certifications issued (new certifications or re-certifications) will be to ISO 13485:2016.
Three years after publication by ISO of ISO 13485:2016, any existing certification issued to ISO 13485:2003 will not be valid.

If you are ready to start planning your transition to ISO 13485:2016 enjoy our blog post on the subject with lots of additional resources that have been added since the original post.

Find out more about this standard from a presentation done back in Feb 2016.  You can get the recording and the slide deck.  You’ll learn how to prepare for the coming regulatory changes, get a general overview of the standard & its most significant changes, and a lot more. Our strategic partners greenlight.guru will ran this free Webinar titled “Understanding the Changes to ISO 13485:2016”. It was presented by Mark Swanson who is a member of the ISO 13485 working group. Click this link to get the on-demand recording.
Also, if you want more info on the standard now you can listen to a podcast on the subject too.

New Strategic Services to help your  

Company in 2016 and into the future

Strategic Reports on Future Development of Standards that impact your Medical Devices

April 2016 Flash Sale on Reports for New Customers & Existing Clients* **

For most companies it is quite expensive to have one of your employees be a committee member for the development of standards.  For example a US company would have to pay annual dues to ANSI & AAMI (AAMI’s dues are based on your Gross profits) for the company & the employee, pay for the travel costs to the meetings, and there is a significant time commitment of the employee for the meetings & additional time commitment expected of committee members to be involved in the standard development process.
There is an alternative to this expensive venture for medical device companies that design & market electrical medical devices.  I, Leo Eisner, can be your eyes and ears so you can learn what the plans are for new and existing standards without the extensive resource and financial commitment to your organization.

These reports are available and if you are a current or past client you get an extra special discount (See * & **).  For the month of April 2016 we have slashed prices for these reports for new customers and deeply discounted the reports for current (project open already) and past clients (See * & ** notes for client rates).

A single report was $3,500 (US$) per report or for both of them was $6,500 (US$) and NOW new customers can get them for only $2,500 (US$) for a single report and both reports for $4,500 (US$).  This is a steal compared to the time I socked into each one of these reports, the meetings I sat in on for 2 weeks in Nov 2015 in Japan (Kobe & Tokyo), and also the money saved not having to be on the committees, the travel expenses for getting to the meetings,  the time in the meetings, and the expected contribution to the standards development for being in these committees.  That is a lot of man hours that you get inexpensively from my hard work.

New Customers can purchase a copy of these reports now. Leo at EisnerSafety dot com or call us at 503-244-6151.

* Current & past Eisner Safety Consultants Clients are eligible for a $1,000.00 (US$) discount if you grab this deal for one reports during April 2016.  So, one report is only $1,500.00 (US$) to my loyal customers during April 2016.  Payment must be by check or bank wire to receive this discounted price.  Please contact us to arrange for this special discount.

** Current & past Eisner Safety Consultants Clients are eligible for a $2,000.00 (US$) discount if you grab this deal for both reports.  So, both reports are only $2,500.00 (US$) to my loyal customers during April 2016.  Payment must be by check or bank wire to receive this discounted price.  Please contact us to arrange for this special discount.
Please contact me with any question on this service at Leo@EisnerSafety.com or 503-244-6151

BIG PRICE DROP ON OUR Standards Reconnaissance Database

Do you need to keep track of standards for your regulatory and quality system requirements? We can do this for you with our Standards Reconnaissance Database.

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The Standards Reconnaissance Service helps medical electrical device manufacturers (our specific focus of our database) keep up to date on new standards, updates to existing standards, and draft standards under development.  This assures you can plan ahead of any major changes.
We reduce your burden on this time consuming task, so you can focus on what you are good at – developing products.

We do this at very reasonable rates.  We have also broken the service in different tiers to match your needs.

The focus of this service will be on the documents for medical electrical equipment & systems (MEE&S = IEC TC 62, SC 62A – 62D) and home use medical electrical equipment & systems (Home Use MEE&S = IEC Active Assisted Living System Committee (IEC AAL SyC) and any other Home Use medical electrical equipment documents from the IEC TC 62, SC 62A – 62D including IEC 60601-1-11 Home Use Environment)

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Available features and additional details on the Standards Reconnaissance Service

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For those that want to test drive the system we do have a free subscription level so you can see how the system works with less details available. To subscribe for the free service level select the Free Subscription Level when Registering on the Subscription Levels page.

Are you ready for the 3 year transition that just started to get your Medical Device Quality System upgraded to meet ISO 13485:2016 and EN ISO 13485:2016?

The sooner you can start on your transition planning the better.

Step 1 – Purchase the standard.  The ISO 13485:2016 and the BSI EN ISO 13485:2016 versions are already available for purchase.

Step 2 – Get up to speed on the standard(s) (ISO 13485 versions that apply and ISO 9001 or other QMS standards that apply to your situation)  – Train your auditors, management (upper and working managers) and your employees that impact quality.

• A good starting point is to hear directly from someone that was on the committee for the standard about the changes.  Mark Swanson did a webinar on the changes to the standard with greenlight.guru, a strategic partner of ours.
• greenlight.guru also has another webinar that can help “How To Prepare Your Organization for the Transition to ISO 13485:2016“
• Some additional resources for learning about this standard include: We have a group of experts within our ranks at Eisner Safety Consultants that can help you train, audit and plan your new QMS.  Also, you can learn from other experts such as from:
  • A podcast on the changes to the standard by Mark Swanson,
  • review BSI’s white paper titled “ISO 13485 – The proposed changes and what they mean to you”, and
  • multiple blog posts by Robert Packard of Medical Device Academy – like Management Review Revisions for ISO 13485:2016 or do a search on ISO 13485 on Rob’s site you will find a wealth of information.
  • Another resource I have been following for many years is Sam Lazzara.   His recent post is titled “(EN) ISO 13485:2016 Medical Device QMS Standard” and he compares the numbering and titles for the requirements clauses between ISO 13485:2003 and ISO 13485:2016 (& also the EN version of the standard). Additional Sam wrote a post related to ISO 9001:2015 that may be of interest as the terms in that Standard are also in the ISO 13485:2016 (At least a portion of them).  The post is titled “Words Matter – ISO 9000:2015 Quality Management System Vocabulary.”
  • TÜV SÜD America will be having a webinar on an “Update on the New CE Marking Rules in Europe” on May 3, 2016 which will discuss among several topics the new revision of ISO 13485.  After the webinar is run their will be a recording available.
  • LNE-GMed March 2016 newsletter has a paper explaining parts of the new ISO 13485:2016.

There are a lot of other resources out there just be careful that you are using a reliable resource (expert) that knows and understands the implications well otherwise you could set your company back instead of moving forward.  So, please make sure to vet any resources.

• As ISO 13485:2016 and ISO 9001:2015 structures are not aligned anymore you will need to consider this if you decide to comply with both.  BSI did a presentation on this subject.
• Part of this training effort may include a focus on Risk Management as ISO 13485:2016 references ISO 14971 so you will want to make sure your workforce is up on this standard as it will impact more people than in the past.

Step 3 – Start planning your transition.  Do you also need to consider ISO 9001 & other QMS standards?

In broad strokes you will need to do at least the following:

• Write Quality Plan
• Determine what changes will impact your QMS
• Update your QMS Manual
• Update your QMS procedures
• Train appropriate staff on the new QMS (Manual, Procedures, Processes)
• Implement QMS
• Run your Management Reviews under the new QMS more often til at least kinks worked out
• Audit new QMS
• Keep at it as Quality is a Continuous Loop System – there is always a way to improve the process and system

Step 4 – Open discussions with your QMS certifier and Notified Body so you stay on track and you get scheduled for your audit before they book up.  With both ISO 13485 & 9001 just being published recently and with the EU New Medical Device Regulation scheduled to be published sometime this year your Notified Bodies and QMS certifiers are going to be busy and book up.  So, plan this out well in advance of when you want your audit scheduled to upgrade to the new QMS standard.

Step 5 – Keep on working thru your Quality Plan to make sure the system is implemented well and continues to work for your company.

A footnote:  The EN version of the standard each EU country’s standards development organization needs to issue a national version of the standard. They have til September 30, 2016 to issue their version of EN ISO 13485:2016. This information comes from the CENELEC & CEN websites on the draft’s of EN ISO 13485:2016.

If you need help with your implementation of ISO 13485:2016 or you are interested in our new Eisner Safety Consultants Standards Reconnaissance Database please email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.

We strive at Eisner Safety Consultants (ESC) to provide the best services for our clients and we have found one that is ideal for many of our small to mid size medical device companies we work with.  greenlight.guru produces an electronic Quality Management System (eQMS) solution built exclusively for medical device companies that is:

• Simple to use,
• integrated product development activities with quality processes,
• is hosted in a secure cloud environment,
• is easy to deploy,
• your team can be spread out all over the world & be able to work on the same documents without any lapse or issues of communication,
• provides easy to use project management tools,
• consolidates your documents into one system,
• helps coordinate your design process into a visual based system that is easy to follow,
• helps fulfill the requirements of ISO 13485, 21 CFR Part 820, and ISO 14971 (& EN 14971),
• has an easy to use document control process,
• and so much more,

This solution will help you ensure compliance, reduce risk and improve team collaboration from the idea stage all the way through post market commercialization. With greenlight.guru’s powerful, easy to use eQMS solution, and Eisner Safety Consultants expertise we will help medical device companies navigate the ever shifting regulatory, quality systems, and product safety environments, enabling them to bring higher quality life changing devices to market, faster – which, after all, is our mission.

To find out more about greenlight.guru please contact Leo Eisner at Leo@EisnerSafety.com or call us at 503-244-6151 or go to our Partners page. We would be happy to discuss the product with you and set you up for a demonstration of the greenlight.guru eQMS solution so you can test drive it to see if it is the right fit for your company.

This posts discusses BSI’s article on the status of the draft ISO 13485:201X standard.  

Recently BSI published an e-newsletter and in it was an excellent article explaining the status of the next draft revision of ISO 13485 and some of the details of the draft standard. The development of this standard project is being managed under the ISO Technical Committee 210, Working Group 1.  The Committee Draft (CD) received over 500 comments and from that the committee published the Draft International Standard (DIS) on 20 Feb 2014.  So, now we are within the required 5 month voting period for comments with the period closing on 20 July 2014.  Note, that some National Committees may ask for feedback up to a couple weeks or more earlier than the 20 July 2014 deadline so get your comments in fast to your National Committee wherever in the world you are.  For most National Committees you or your company have to be members of that committee to submit comments. Note, that since this is at the DIS stage of the process these comments, unless really minor typos, typically will not have an impact on the 3rd revision of the standard but will probably have to wait til the next revision cycle of the standard as at DIS you can’t make any technical changes to the standard. This stage is fairly late in the process and so you aren’t typically allowed to make these types of changes based on how the process is structured in the ISO and IEC standards development process.

When is it anticipated this standard will be released?

The article goes on to say if things run smoothly you may be able to see the actual published standard by late 1st quarter 2015 or early 2nd quarter 2015.  It is expected that there would be some type of transition period established for this standard and this may be impacted by things like the publication of ISO 9001 which this standard relies on, supporting the existing European Medical device Directives and the upcoming Medical Devices Regulations.

The article mentions that you can view a copy of the draft on the BSI National Standards Body website or you can buy a copy as noted in the article. 

If you need additional support in the standards development process for a standard email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151 as he is a Convener for an IEC/ISO, EN and ANSI/AAMI standard for IEC/ISO 80601-2-58 on Lens Removal and Vitrectomy Equipment. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

One of the first questions clients ask before a project starts is, “Does this medical electrical product fall under IEC 60601-1?” Another common question clients ask is whether IEC 60601-1 applies to battery operated medical devices. To answer these questions, we must review and understand the scope (sub-clause 1.1) of IEC 60601-1 to determine if and how the IEC 60601-1 Standard applies to a medical electrical product.

This blog discusses the following points:

• Definitions
• Examples within Scope of IEC 60601-1:2005
• Examples not within Scope of IEC 60601-1:2005
• IEC 60601 & ISO 13485
• Third-Party Testing

We also set-up pages to do the same for checking on the status of the IEC 80601 series of current & draft standards, which are standards that are jointly developed between IEC & ISO, and TRFs of the current 806012 series standards.  These later standards are called either IEC 80601-X-Y standards or ISO 80601-X-Y standards.  The lead organization gets their organization initials in the standards identifier.

This is a great resource to be able to stay up to date on the standards that are being developed, the updates to current standards and to ensure your standards library is up to date as required under ISO 13485 and also under most medical device regulatory national schemes.  If your organization needs help keeping track of current &/or developing standards our organization can help you develop a system or we can do this work for your organization’s standards and external documents library.  Please feel free to contact us about this at Leo@EisnerSafety.com or 503-244-6151.

Joe Hage (www.medicalmarcom.com) will be offering a free webinar, taught by Rob Packard and Brigid Glass, on the “Best Practices in Medical Device Auditing”. If you want to be part of this I suggest you click http://medgroup.biz/best-audits right now to register, because 1,000 seats is the maximum available and 250 people signed up in the first 24 hours, about a day ago.

The free webinar, scheduled for Wednesday, February 13^th, 3 – 4pm (PST) or 6 – 7pm (EST), will include 10 minutes on the topic of Turtle Diagrams, a 15 minute video by Brigid Glass about audit program planning, and Rob will close with about 15 minutes explaining how the topics Brigid mentioned can be applied to planning an audit. The 10 minutes Rob will spend on the topic of Turtle Diagrams is not really long enough to cover the use of the process approach in detail.  

Rob mentioned to me that he is also teaching a 1-hour audio seminar through FX Conferences on Tuesday, February 19th, 8:30am to 9:30am (PST) or 11:30am to 12:30pm (EST). That audio seminar will be specific to the topic of Turtle Diagrams and the Process Approach. http://www.fxconferences.com/Adding-Value-to-Audits-Using-the-Process-Approach-P1170.aspx

Also, check out http://MedicalDeviceAcademy.com. Rob and Brigid will be teaching a live, two-day course on Best Audit Practices in April. Only 60 seats (20 per city: San Diego, Orlando, Las Vegas).

“The purpose of this questionnaire is to determine the need for modification or updating of the ISO 13485:2003 requirements standard and the ISO/TR 14969:2004 guidance document.”

From what the full text on LinkedIn says ISO 13485 will be getting an update either way but this way you can provide feedback, to the authors of the standard, as to what you think and maybe that can have some impact on the development of the next edition of the standard.  If you are a medical device company and interested in responding to this survey you can access it by clicking here.  It asks some really good questions and hopefully your feedback will help the development  of the standard.

Thx Marcelo for posting this survey.

From the FDA CDRH webpage titled “Documents the CDRH is Considering for Development (FY11)” the following is the intoduction to the page:

“This is the list of guidance documents CDRH is considering for development this year (2011). CDRH plans to update this list every year. CDRH invites interested persons to submit comments on any or all of the guidance documents on the list to docket FDA-2007-N-0270. Comments may include draft language on the proposed topics and/or suggestions for new or different guidance documents. CDRH believes this docket is an important tool for receiving information from interested parties and for making information available to the public.

The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CDRH has already issued Level 1 drafts that may be finalized following review of public comments. This list of proposed guidance documents is not binding. CDRH is not required to issue every guidance document on the list and may issue guidance documents not on the list.

Current FDA and CDRH guidance documents can be found on the CDRH Guidance Document page.”

Further along in the description of the process the FDA CDRH says this process is to “provide stakeholders an opportunity to provide comments and/or draft language for those topics as well as suggestions for new or different guidances.”

After talking with the FDA Oct 5 with one of the people that has written some of the draft guidances that will come out later this year he indicated that if the document comes out for public review & comment and there is no feedback that doesn’t make the document as good as it could be.  The FDA is really seeking feedback on the draft guidance documents to make them much better and to be useable by the stakeholders.

The webpage http://ht.ly/2OiXg where the CDRH is considering documents for FY11 has instructions on how to comment on these draft guidance documents.

Also, at the bottom of the webpage http://ht.ly/2OiXg there is a list of “What guidance document is CDRH considering for development during FY 2011?”  The list is over 40 items long and covers areas such as product specific, safety standards, medical device quality systems, guidance on postmarket and compliance issues, among other areas.  Below is a list of some of the draft guidance they hope to publish and get comments on in their FY 11.  Note that not all of these will make it out of FDA by the end of their FY11 (ends Sept 2011):

• Application of IEC 60601-1 Third Edition
• Medical Device ISO 13485
• Radio-Frequency Wireless Technology in Medical Devices
• Medical Device Appeals and Complaints: Guidance on Dispute Resolution
• Medical Devices Containing Materials from Animal Sources (except IVDs)
• Medical Device Home Use
• Medical Device Premarket Clinical Studies: Levels of Evidence
• Manufacturing Site Change Supplements: Content and Inspectional Considerations
• Medical Device Reporting for Manufacturers
• “510k Actions”‐FDA and Industry Actions on Premarket Notification Submissions
• Distinguishing Medical Device Enhancements from Product Recalls and Corrections
• Electronic Medical Device Reporting
• Computed Tomography
• Implantable Cardiovascular Defibrillators
• Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data
• Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data
• Pediatric Information in Diagnostic Medical Device Premarket Submissions