FDA To Launch Electronic Submission Pilot For Home-Use Device Labeling
In an effort to improve patient safety in home healthcare environments, the FDA’s Center for Devices and Radiological Health (CDRH) has launched a new pilot program that will develop and test the efficacy of an online database for home-use medical device labeling. The FDA is currently seeking home-use device manufacturers to participate in the Electronic Submission for Home Use Device Labeling Pilot Program.
Devices used without the supervision of a trained health professional present a unique set of risks and challenges and require extra care with their labeling, the FDA expressed in a document recently published in the Federal Register. By developing and maintaining a database of pertinent safety information and instructions, the FDA hopes that patients and home healthcare providers will be better equipped to use all currently available products.
“Risk minimization is accomplished, in part, through clear communication on the benefits and risks of the medical devices regulated by the Center, including communications by CDRH, product manufacturers, and product distributors,” the FDA wrote.
The program will build upon the FDA’s Medical Device Home Use Initiative (MDHUI), introduced by the FDA five years ago.
“Posting medical device labeling in a single online location will make it easier for home care patients and caregivers to find important information about how to safely use their device,” the FDA wrote in a document about the MDHUI published in 2010.
The FDA acknowledges that many device manufacturers are already publishing clear labeling for their products both as packaging inserts and on websites. However, the agency argues that these websites tend to focus on the most recently released products and do not usually provide labeling for older devices that are not being actively marketed. Furthermore, device inserts can get separated from a product after several years of use and may not provide the most updated safety information.
The databased proposed by CDRH would allow for broad searches of available medical devices based on a given need and also more specific searches for information regarding a particular product.
“This database would fill an important gap in the information available to patients, caregivers, and the healthcare community concerning home-use devices,” said the FDA.
The FDA will be accepting applications from May 1 to May 31, 2015 and the program will run for six months starting in July of this year and finishing in December. For the duration of the pilot program, the database will not be available to the public.
Last year, the agency also issued and soon after updated final guidance clarifying design considerations for devices intended for home use.