The Federal Register notice (FR Notice) continues with details about the workshop.  The public workshop is free with registration (please register early) and will be held on April 29 – 30, 2013 at the FDA White Oak Campus at 10903 New Hampshire Ave, Bldg 31 Conference Center, the Great Room (room 1503A), Silver Springs, MD 20993. To register for the workshop visit the FDA’s Medical Devices News & Events – Workshop & Conferences calendar.  There is also an option for a Webcast to view the workshop from off-site web facilities.  To sign-up in this way use the same registration link as above but make sure to note that you want to attend via a webcast vs in person.  The contact person for this workshop is Mary Brady, Mary.Brady@fda.hhs.gov who is also involved with the Home Use Medical Device Initiative so this is a good tie-in with that subject as labeling is critical to get consistent for ease of use or Usability (or Human Factors some call it).  Refer to the blog post on the Home Use Medical Device Draft Guidance document that was issued on 12 December 2012 for details about the Home Use Draft Guidance document and also about the Home Use Initiative.

In the background section of the FR Notice for this Workshop FDA indicates “Currently, there are no regulations that explicitly define and describe a standard content and format for medical device labeling. FDA is concerned that the lack of standard content and format may translate into an increased risk of medical device error. Also, there is no single available source of medical device labeling for people to view, search, and download for devices that are used in clinical and non-clinical environments. FDA is aware of and concerned with the risk of medical errors that result from lost or inaccessible labeling.”

FDA also conducted a 2-phase research study with Research triangle Institute (RTI) of healthcare professionals in regard to their experiences with medical device labeling, and what they would like to see in a standardized version of device labeling. Key findings from the study helped create an outline for standard content and format for medical device labeling id’ing the most relevant sections.  Also, survey participants asked for a “quick reference guide”  for proper device operation & use.  They indicated that would be more convenient and effective with the option of referring to a more comprehensive form of labeling.

Additionally FDA also conducted a survey of the National Family Caregivers Association (NFCA) on medical device labeling to elicit home caregivers’ experiences with medical device labeling for devices used in the home environment.  Here again is another tie-in with the Home Use Medical Device Draft Guidance document and blog post on this subject.  It is clear this initiative is tied-in with the Home Use Initiative and will help support each of the initiatives.  FDA continues to say in the FR Notice “As more medical devices migrate out of clinical care environments and into patients’ homes, the assurance that devices are being used properly and safely no longer resides with a healthcare professional; rather, the responsibility is with the patient, spouse, sibling, or even children. When medical devices are sent home with patients or are moved from one location to another, the labeling often becomes misplaced, lost, damaged, or discarded, which may result in adverse events or other complications due to misinterpretations and absence of proper labeling.”

Per the FDA FR Notice the workshop will focus on the following topics for discussion

A. Summary of FDA Work on Labeling

1. RTI two-phase research study of healthcare professionals regarding device labeling.
2. NFCA survey of consumers on medical device labeling.
3. Cooperative Research and Development Agreement with Kwikpoint for the development of visual language for device labeling.
4. The Center for Drug Evaluation and Research measures of success with standard labeling and the use of a drug repository.

B. Standard Content and Format of Device Labeling

1. Review the outline for a draft standard content and format of medical device labeling.
2. Current thinking on a standard content and format of medical device labeling.
3. Use of symbols in medical device labeling.
4. Discuss a shortened version of standard medical device labeling.

C. Repository of Medical Device Labeling for Home Use Devices

1. Online access to device labeling.
2. Panel discussions on using an online device labeling site.
3. Discuss the types of devices whose labeling should be on the site.

For additional information on the topic also refer to the RAPS News article on 4 Jan 2013.

First a closing statement press release from the GHTF president was issued recently (dated Nov 2012) and on the International Medical Device Regulators Forum (IMDRF) webpage for the Archived GHTF documents there is a statement at the top of that page stating:

• “Important! The organisation GHTF no longer exists, and has been permanently replaced by the IMDRF. All material appearing on this page and the pages within has been moved here from the old GHTF site for preservation, and is no longer current. It is historic information and should not be acted upon.”

Another point to note is that the last set of documents from the GHTF were issued on 2 Nov 2012 and the IMDRF website in the last couple days seems to have been totally updated and reorganized in an easy to use format that will make it easy for the public to view this valuable resource and to stay up to date on the happenings of this organization.   Hopefully,  in the next decade, or sooner, the IMDRF will begin the process of Harmonizing areas of the international medical device regulatory arena so medical device manufacturers won’t have to deal with varying regulations through out the world.

On the Archived GHTF webpage it also states that they have brought all of the current and archived GHTF documents over to the IMDRF website.  Note, that the GHTF website is still up but it is not clear what will happen to it or when it will be taken down.

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More about the IMDRF: Straight from the IMDRF website the following gives you some information about the organization.  If you have furhter questions about the organization please contact the IMDRF secretariat at imdrf.secretariat@tga.gov.au

IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.

IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum. A copy of the outcome statement from this meeting is available from the Meetings page.

Further information about the work and operations of IMDRF is available in its Terms of Reference (Note, the last page of this document has an organizational chart showing the roles and inte-relations of these roles).

On the About Us webpage  they go on to describe the different roles and responsibilities within the IMDRF.   The functions described are the IMDRF Management Committee; the Management Committee Members (Australia, Brazil, Canada, Europe (the EU), Japan, and the USA);  Official Observers (World Health Organization {WHO}); Affiliate Organizations; and Working Groups.

RAPS Regulatory Focus Article posted 30 Oct 2013 on the subject is interesting and provides some additional background and perspective.

Per the Interpretation issued  e-labelling refers to the information required by section 21(1) of the Regulations (Medical Devices Regulations – SOR/98-282) that would ordinarily be found in the directions for use. Per the notice:

“The directions for use may include a surgeon’s instruction manual, operator’s manual, or user’s manual. At this time, the only acceptable electronic media in which to present information to satisfy the labeling requirements of section 21(2) of the Regulations are those described below.

Electronic labelling may be provided on Compact Disc (CD) or Digital Video Disc (DVD), accompanying the device at the time of sale and/or delivery….The CD/DVD must be packaged with or accompany the device in a manner that alerts the user to its purpose. The information provided on CD/DVD should be easily navigable.

For the following two categories of devices…, this information may, in the alternative, be provided in downloadable format from the internet: Class IV medical devices and in vitro diagnostic devices (IVDDs) that do not fall within the definition of near patient IVDD. The internet address must accompany these devices at the time of sale and/or delivery, and be displayed in a manner that alerts the user to its purpose…

Manufacturers should ensure that the labelling information provided in electronic format is identical in content to the paper format submitted with the device licence application…

Upon request, a paper copy of the label information should be provided promptly to the user, without additional cost.

Since this Notice is permissive in nature, it is effective immediately….”

For full text of the notice click here or go to the Health Canada webpage for this notice.