Tucked away in the Federal Register are the FDA's intentions to test its own labeling format to "inform FDA's planned regulatory approach to standardizing medical device labeling across the United States."
The test will consist of 38 respondents (including 8 at participating hospitals and 30 at FDA headquarters) that will compare the possible standardized labeling format of the future against existing device labeling. The study will compare both forms of labeling related to 6 different devices.
For reference, consider the standardized labeling formats applied to food and drugs. "Building upon the research methodology and success of the approach FDA used to evaluate drug labeling, we propose to measure the usability and usefulness of a draft standard content and format of device labeling against existing manufacturer labeling of the same device," the Federal Register says.
This is not the first time the FDA has made noises about standardized labeling in the Federal Register, the Regulatory Affairs Professionals Society points out. In January 2013 the agency wrote that there is a "growing need for medical device labeling to be delivered in a clear, concise and readily accessible format so that patients, caregivers and healthcare providers may access and utilize device labeling as efficiently and effectively as possible."
In addition, there is no medical device equivalent to DailyMed, the agency said in 2013: "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 nonclinical environments." (Run by the U.S. National Institutes of Health, DailyMed provides a downloadable and up-to-date repository of medication package inserts.)
And the FDA invites comments on the proposed study, including "ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology." Also requested are comments on the study's estimated burden (2-4 hours per respondent), practical utility and ways to enhance the quality of the data of information to be gathered.
The notice in the Federal Register is required 60 days before submitting the request to the Office of Management Budget for Approval.
AdvaMed came out against the idea of standardized labeling and a centralized labeling repository. "We believe there are significant challenges to developing a standardized label akin to pharmaceuticals because of the greater complexity of medical technologies and their vast variety. It is important to remember that medical technology companies must validate their instructions for use as part of their quality system design control requirements to ensure they are appropriate and useable," Jeff Secunda, VP of technology and regulatory affairs, said in an email to FierceMedicalDevices.
He continued, "Due to the rapidly evolving nature of medical devices and diagnostics, we believe a centralized downloadable repository of medical device labeling and inserts would be problematic in terms of assuring that patients and healthcare providers have access to the correct information."
- read RAPS' take
- here's the notice in the Federal Register
Editor's Note: This article has been updated with AdvaMed's reaction to the proposal.