Just received an e-mail update on the status of the DRAFT NB-MED document on 3rd edition of EN60601 Implementation for the EU. The pertinent points are:

1) Substantial progress has been made over the last couple months on the document

2) The NB-MED has presented their observations and comments on the proposed document to the team proposal early in Dec 2011

3) The team has worked on integrating the observations and responding to the comments

4) on 13 Jan 2012 the group forwarded their results to the NB MED working group for their approval (validation).

5) It is expected that this document will formally be published hopefully within a couple of weeks not months.

For more details on this DRAFT document please go to http://wwww.EisnerSafety.com/draft-results-implementation-of-3ed-en60601-series-for-ce-marking/ for a copy of the DRAFT document and
http://www.eisnersafety.com/eu-en-iec60601-1-3rd-ed-request-for-issues-on-the-use-of-the-std-for-ce-conformity/ for the first announcement about this process.

In the Federal Register Notice the FDA said “The agency believes that this wil allow adequate time for interested persons to submit comments without significantly delaying action by the agency.”

Per a Mass Device web article of November 8, 2011 “The draft guidance is intended to update a 1977 guidance document, ‘Deciding When to Submit a 510(k) for a Change to an Existing 510(k).’ It aims to clarify when a new 510(k) pre-market notification should be submitted for a change or modification to a device that’s already won 510(k) clearance.”

The draft guidance document states in section IV: “This guidance explains FDA intentions to apply its regulatory requirements to a subset of mobile apps. This subset, which we are calling mobile medical apps as defined in section III (definitions), includes only those that meet the statutory definition of a device; and either:

• are used as an accessory to a regulated medical device;
• or transform a mobile platform into a regulated medical device.

This guidance does not specifically address wireless safety considerations, classification and submission requirements related to clinical decision support software, or the application of quality systems to software. The FDA intends to address these topics through separate guidance(s).”

Also, the draft guidance details a long list of app’s that don’t fall under this draft guidance document.

On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information can be found on our blog post on this topic.

On March 4th  join Leo Eisner in Foster City, CA as he & several other presenters focus on the topic of “Evolving Risk-Based Regulatory Requirements” for a whole day workshop put on by RAPS (SF Bay Area Chapter) & ASQ (Biomedical Division Northern CA Discussion Group).  Leo will be presenting on the 3rd ed. of IEC 60601-1, the series of standards, and also the impact of change on the medical device industry.  Other topics will include Usability & Human Factors verification, validation, and regulatory requirements; and Clinical evaluation & investigation regulatory requirements. More information can be found on our blog post on this topic.

Biomedical Division Northern California Discussion Group  andSan Francisco Bay Area Chapter

Topic: ”Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas:

• IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration, and the impact of change on industry
• Usability and Human Factors verification, validation, and regulatory requirements
• Clinical evaluation and investigation regulatory requirements

Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Geetha Rao, PhD, VP, risk management and strategy, Triple Ring Technologies, Inc; Ibim Tariah, technical director, BSI Healthcare; Craig J. Coombs, RAC, president, Coombs Medical Device Consulting, Inc.; and Juergen Stetin, president and CEO, PROSYSTEM AG 

When: March 4, 2011 (Friday), presentations start right at 8:30AM check-in 7:45AM with Continental Breakfast

Registration Contact: Wesley Carr or call +1 301-770-2920 ext. 231 Registration form for event, must register by Feb 25, 2011, space is limited

Where: Crown Plaza Mid-Penisula, 1221 Chess Drive Foster City, CA 94404

You can view the current & previous lists which shows all the Fed Reg publications of the Lists.  The best way to use this system of Recognized Standards List is to access the Database.

This issue we are going to focus on primarily on IEC/EN 60601-1:2005/2006 as there is some significant news within the last few weeks and more to come really soon.  Also, we would be remiss if we didn’t remind you that the MDD Amendment 2007/47/EC becomes mandatory this weekend on March 21, 2010.  There is no transition period for the amendment to the MDD.

First, we are presenting an audio conference titled “Is Your Product Development Cycle Ready for IEC 60601-1 3rd Edition?” which will be on March 25^th.  Please come and join in the audio conference.  See below for a special discount code that only Eisner Safety Consultants is able to provide to you.  Next we want to remind you about the MDD Amendment deadline and that we can help you out with our MDD Amendment Toolkit, which is only $249.00.  Our third article summarizes the recent important information related to 60601-1, 3^rd ed. and related standards.  This is a must read especially the part with the FDA.  Lastly, we let you know that there are 3 different ways to get up to date notices from Eisner Safety Consultants (ESC Updates) on the medical device industry regulatory, product safety and quality system news.

If you have any questions regarding any of the subjects of this newsletter please feel free to contact us.  We hope you enjoy our fifth newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

To see past editions of the newsletter go to www.EisnerSafety.com/esc-news/. Subscribe to the newsletter to get future newsletters.  Go to any page on the website and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.

Article reprinted from “The Gray Sheet” – March 15, 2010

FDA is exploring ways to inform industry of changes to its regulatory expectations more quickly than guidance documents or standards development allow, device center director Jeffrey Shuren said last week.

The center is trying to determine when and how to update manufacturers on revisions to standards for getting a new product to market, Shuren explained March 10 at the annual standards and regulation conference hosted by FDA and the Association for the Advancement of Medical Instrumentation (AAMI).

“We may say, ‘We expect a change in design, we may expect a change in how that product is assessed,’” Shuren said. “Well, every time we make that decision, if you’ve got a device in the works, you are going to have to make a change.”

Requiring these changes on an ad hoc, case-by-case basis does not benefit device makers, Shuren said, acknowledging longstanding industry concerns.

But the guidance development process can be slow and requires “a lot of resources,” he noted.

“One of the things we’re thinking is, are there other mechanisms by which we can convey our expectations in a more timely manner, and can we be a little bit more predictable about when our expectations change?” he told conference attendees.

Guidance Development: A Cumbersome Process

Maggie Dietrich, special assistant to Shuren, also pointed out that writing guidance documents, one of FDA’s key methods of communication, is “a very cumbersome process.”

The device industry prefers guidance development, with the industry input it entails, as a way to communicate changes in regulatory expectations. But companies agree that it is important to communicate requirements “as quickly as possible,” Janet Trunzo, executive VP of technology and regulatory affairs at AdvaMed, said in an interview.

“If FDA believes that the guidance document process and internal review process at FDA takes too long, FDA could at least communicate through stakeholder meetings … or perhaps issuing points to consider or the outline of the guidance it is thinking of developing,” Trunzo said.

FDA has already taken steps to improve other early communications tools, such as public health notifications, over the past years, Dietrich said at the FDA/AAMI conference.

“We put out early communications where there’s a concern for us but we’re not quite sure what to do with it, but we want to get people’s attentions to make sure that they understand the state of our current knowledge,” she said.

But AdvaMed has voiced some concerns with this approach.

In February comments to FDA on the issue of incorporating new science into regulatory decisions, the association said the agency has failed in the past to discuss issues involved in public health notifications with all relevant stakeholders, such as device firms or clinicians, leading to “biased notices.”

CDRH Plans Continuum Of Communications

Shuren suggested that companies consider quicker communications tools as part of a continuum.

“We may have a tool by which we say, ‘In this case, here’s what we’re thinking now,’ and we’ll do it fast,” he said. “We might then move to a guidance to provide more details. And then we may still be working on a standard to ultimately put out.”

He pointed to the center’s recent initiative on reducing unnecessary radiation exposure during medical imaging procedures, which involves an FDA white paper, a public meeting this month and, eventually, new rulemaking and guidance (The Gray Sheet’ Feb. 15, 2010).

FDA’s communications overhaul is part of the device center’s broader work to increase transparency, which is a strategic priority for 2010 (The Gray Sheet’ Jan. 25, 2010).

According to a priorities report issued in January, CDRH plans to implement a “strategic communication program” by the end of September.

- Jessica Bylander

A draft guidance has been issued for comment purposes only, see “Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications” issued March 13, 2009, which if issued as final, will replace the currently available guidance which was issued on November 24, 2003.