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FDA Seeking Safer Medical Devices Through eLabeling Pilot

Posted 20 April 2015 | By Alexander Gaffney, RAC

FDA Seeking Safer Medical Devices Through eLabeling Pilot

Medical devices used in home healthcare settings may soon be made safer thanks to a labeling program being piloted by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH).


In general, medical devices can be divided into two categories: those intended to be used in professional settings by healthcare professionals, and those intended to be used in home healthcare settings by patients or caregivers.

The latter category, often referred to as "home use devices," is associated with a unique set of concerns compared to its professional use counterparts. Because the devices are typically used by those without medical training, FDA has taken an interest in making sure that they are designed and labeled appropriately for use within the home.

Since 2010, FDA has been working to improve the safety of these devices through its Home Use Devices Initiative.

One part of that initiative has been focused on the proper design and testing of home use devices. For example, a new guidance document released in August 2014 and updated in November 2014 explains the design considerations each manufacturer should take into account when creating and testing a home use device.

A Focus on Labeling

The other half of FDA's Home Use Devices Initiative is focused on labeling, and specifically the creation of a "labeling repository for medical devices that have been approved or cleared for home use."

The problem is related to a broader problem within the medical device industry: Unlike pharmaceuticals, medical devices do not have a standardized labeling format.

For home use devices, which might be used in a home for years and be separated from their original packaging and instructions, that can represent a major challenge for both patients and providers, FDA says. "Health care professionals … need ready access to labeling that may not always accompany a medical device," the agency explained on its website.

"This labeling can be essential for home-use devices, which are much more likely to be used by lay users, who frequently have not been trained to use such medical devices and who are especially reliant on the instructions for use and other information provided by the device label and package insert," FDA added.

So in 2011, FDA launched a "preliminary labeling repository" pilot program intended to work out how device manufacturers could voluntarily submit their device labels to FDA. The program was used to "identify the best approach to foster the development of a labeling repository," FDA recalled on its website.

The aim of the labeling repository: Labels that are simpler to understand and available when and where caregivers need them.

A New Pilot

Now FDA is rebooting its original labeling repository pilot program, seeking to expand the scope of its participation and labeling content.

In a 17 April 2015 Federal Register announcement, the agency said it is continuing to develop an "electronic submissions database, accessible to the public through FDA"s website, of labels and package inserts for listed home-use devices."

The intent of the database is to be a valuable asset for home health providers, who could use the database to access the latest safety and use information for a device. "The database would allow both broad searches to identify legally marketed home-use devices that may fill a particular need and focused searches to obtain information concerning the use of a specific home-use device," FDA explained.

FDA is set to evaluate the latest iteration of its database in a six-month pilot program. In addition to the basic devices labeling, the pilot will also assess FDA's electronic submissions system and package inserts.

The pilot program will begin on 1 July 2015 and last until 31 December 2015.


Federal Register Program


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