Regulatory Focus™ > News Articles > FDA Looks to Establish Standardized, Mandatory Labeling Format for Medical Devices

FDA Looks to Establish Standardized, Mandatory Labeling Format for Medical Devices

Posted 04 January 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) is preparing to hold a public meeting during-and before-which it plans to solicit comments on how to standardize the labeling found on medical device products in a way more similar to that of pharmaceutical products.

At present, there are no regulations defining a standardized approach for how content should be structured or formatted on a medical device. This is considerably different than other FDA-regulated products, such as food or pharmaceutical products, which are required to adhere to strict requirements regarding everything from the font size and required information to layout and required statements. The logic behind the push to standardize medical device labeling is the same as it is for existing labeling conventions, FDA explained.

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," FDA wrote in a 4 January 2013 Federal Register posting announcing the meeting.

Patient safety may also be negatively affected by the absence of a standard, FDA explained. "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." Unlike pharmaceutical products, which typically have a shorter shelf life, the longevity of medical devices may mean that their instructions for use and warning labels are damaged or illegible after a few years. If these labels are unavailable, patients may be harmed in the process.

But patients could also come to harm even if the labels are present, FDA said. "FDA is concerned that the lack of standard content and format may translate into an increased risk of medical device error," it wrote. If a warning section, for example, is placed in an unusual section, a physician may inadvertently skip over it, potentially subjecting a patient to unnecessary harms.

With these facts in mind, FDA said it has already contracted a two-phase research study with Research Triangle Institute to poll "healthcare professionals" on what information they would want in a standardized device label. The information obtained from that research has since been turned into an outline for a standard format, but FDA noted participants in both that study and a subsequent one expressed a desire to see a kind of "quick guide" to describe the device's most critical information in an at-a-glance format.

FDA's workshop is aimed at providing a public summary of its research findings, as well as reviewing its draft outline for medical device labeling and the potential use of symbols in medical device labeling-something it has previously announced in its Unified Agenda, and something that will likely become a regulation of its own at some point in the next few years.

FDA also said it will propose a new online database to provide online access to a catalog of medical device labels-something it noted is particularly important for medical devices used in home healthcare settings.

"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," FDA explained. "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."

Registration for the public workshop, which will take place 29-30 April 2013, is free and must be completed by 5 April 2013. The workshop will also be streamed online here.


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