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Summary:
This issue is packed full of important updates and useful information. First, we are going to focus on additional updates with regard to IEC/EN 60601-1:2005/2006 as there is significant news since the last issue of our newsletter.

Next we delve into the MDD Amendment 2007/47/EC specifically on the updated Classification MEDDEV and the new Clinical Data requirements. We also would like to remind you when your EU MDD Notified Body is up to reviewing your technical file or design dossier you need to make sure you have addressed the Usability and Clinical Data requirements as they apply to all medical devices under the MDD Amendments. If you need help with these new requirements to the MDD we have a toolkit that will be helpful to you.

Lastly, our Associate Christine Ruther writes about an FCC publication in regard to medical devices that use inductive coupling to recharge batteries.

We hope you enjoy this edition of the newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

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There is additional information, including how collateral and particular standards will be treated and how US National infrastructure requirements enacted as statue (e.g. NFPA 99) will be implemented with this Standard, and how Risk Management will be used with this standard, on the FDA Consensus Standard web page for ANSI/AAMI Es 60601-1:2005 http://ht.ly/22kSQ

Summary:  The FDA and the FCC are jointly sponsoring a public meeting entitled “Enabling the Convergence of Communications and Medical Systems: Ways to Update Regulatory and Information Processes.”The purpose of this meeting is to identify the challenges and risks posed by the proliferation of new sophisticated medical implants and other devices that utilize radio communications to effectuate their function, as well as challenges and risks posed by the development and integration of broadband communications technology with healthcare devices and applications.

Dates and Times: The public meeting is scheduled for July 26 and 27, 2010, from 8 a.m. to 5:30 p.m. Persons interested in attending and/ or participating in the meeting must register by 5 p.m. EDT on July 19, 2010. Submit either electronic or written comments related to the agenda, by 5 p.m. EDT on June 25, 2010.

Location: The public meeting will be held at the FCC Commission Meeting Room, 445 12th St. SW., Washington, DC 20554

Contact Persons: Bakul Patel, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm. 3543, Silver Spring, MD 20993, 301-796-5528, email: bakul.patel@fda.hhs.gov; or Bruce Romano, Federal Communications Commission, 445 12th St. SW., rm. 7-C140, Washington, DC 20554, 202-418-2470, email: bruce.romano@fcc.gov.

Registration and Requests for Oral Presentations: Registration requests must be received by 5 p.m. EDT on July 19, 2010. Interested persons may register by emailing FCC-FDAMeeting@fcc.gov

Available Twitters as of May 14, 2010

• FDADeviceInfo – Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.
• FDAcdrhIndustry - Helpful links, information, and news for industry related to medical device and radiation-emitting products.

From  FDA News Devices & Diagnostic Letter March 29, 2010

Devicemakers may have to pay up to 40 percent more to test the safety and effectiveness of electronic devices now that CDRH has adopted an international standard for electronic devices.

Manufacturers will have three years to comply with the third edition of the International Electrotechnical Commission’s (IEC) 60601-1, Carol Herman, director of standards management at CDRH, said at a recent Association for the Advancement of Medical Instrumentation (AAMI) conference. The agency hopes to publish a notice of the change in the Federal Register by June, she added.

Many Changes

The complex standard sets general requirements for basic safety and essential performance of medical electrical equipment. Unlike most revisions, which average three to five major changes, the third edition of the IEC standard includes 114 subclauses not listed in the second edition, introduced in 1988, John Drengenberg, consumer affairs manager at Underwriters Laboratories, told D&DL.

The new standard allows devicemakers to employ less stringent requirements for operator safety, mechanical safety factors and surface temperatures, Frank O’Brien, president of O’Brien Compliance Management, told D&DL. But for electronic devices on wheels, the standard includes more stringent requirements for stability and rough handling.

The standard also allows devicemakers to use components, such as power supply units, designed for the IT industry, which could offset other costs, Mike Schmidt, co-chairman of AAMI’s electrical safety committee, told D&DL.

To help devicemakers transition to the new standard, CDRH plans to release two guidances. The first, which should come out sometime this year, would cover general principles of how to use the standard based on the FDA’s perspective of safety and effectiveness, Leo Eisner, a safety consultant who has worked with FDA officials, told D&DL.

The second guidance, which will not be issued until the FDA determines what changes to make to its 510(k) and PMA processes, will advise manufacturers on what information will be required in marketing applications for electronic devices, he said.

Harmonizing Standards

CDRH’s adoption of the IEC standard was inevitable given the FDA’s push to harmonize its regulations, Steve Strong, vice president of quality assurance and regulatory affairs at Minnetronix, told D&DL. Minnetronix specializes in the design and manufacture of electronics-based devices.

With Canada, Europe and the U.S. in various stages of implementing the IEC standard, 75 percent of device regulators should be in alignment with the provision by 2013, O’Brien said.

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

From AAMI March 12, 2010 press release

The U.S. Food and Drug Administration (FDA) will formally recognize the electrical equipment standard IEC 60601-1/Ed.3:2006.

Carol Herman, director of standards at the FDA’s Center for Devices and Radiological Health (CDRH), made the announcement during the Association for the Advancement of Medical Instrumentation (AAMI)/FDA International Conference on Medical Device Standards and Regulation, which took place in Reston, VA, March 9-10.

“We will not only recognize the third edition of the standard, but we will also recognize all collaterals and all particulars,” Herman told attendees.

The third edition of 60601-1 offers general requirements for basic safety and essential performance of medical electrical equipment. It also contains requirements for reliable operation to ensure safety.

CDRH hopes to publish notice of the recognition in the Federal Register by June, Herman said. Once the notice is published, users will have three years to transition to the third edition and the related collaterals and particulars, Herman added.

The standard already has been recognized and harmonized in Europe for the last several years, said Charles Sidebottom, director of corporate standards for Medtronic and secretary of IEC/Sub Committee 62A, which developed the standard.

Sidebottom, who is chair of AAMI’s Board of Directors, says that the subcommittee has been working with CDRH staff to get the standard recognized since well before it was even published. “For us that is a real big deal that the agency formally announced recognition of the whole collection of standards,” he said.

AAMI had adopted its own version of the standard with national deviations called ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD), which includes original IEC text where U.S. modifications are introduced for easy comparison of requirements, as well as a number of the collateral and particular standards.

Changes on the Horizon

The CDRH recognition comes as a new amendment to 60601-1 is under development, which includes some changes to the original standard.

One of the proposed changes focuses on extending the scope of 60601-1 to include medical software systems. The amendment includes a definition of medical software systems and associated technical requirements.

The amendment also aims to streamline the application of risk management. It clarifies how a manufacturer should apply the standard’s requirements when evaluating residual risk, Sidebottom said during a presentation at the conference. When there are specific requirements with specific acceptance criteria, compliance is “presumed to establish acceptable risk,” Sidebottom added. The amendment also revises how to establish alternative risk controls or test methods.

The amendment clarifies the definition of essential performance to more fully explain the process for identifying essential performance and mitigating the risks associated with its loss or degradation, said Sidebottom. “Essential performance is performance other than that related to basic safety,” he said. “In many cases, differentiating between basic safety and essential performance is not that important because the standard says both have to be maintained. However, in some cases it is important to draw that distinction so the standard needs to be clearer about how the manufacturer should go about identifying the essential performance.”

The amendment is expected to be published in August 2013.