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.

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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.