Medical Device Labeling in FDA’s Cross-Hair
[Posted on: Thursday, August 6, 2015]

FDA does not have a process for formal review of labels or advertisement material for approved medical device intended for patients and lay caregivers. Most Class I and several Class II devices do not require a doctor’s supervision to buy or use a given medical device. Historically, it was acceptable as most medical devices are used under supervision of a doctor and patients rely on their physician’s instructions. However, in the last decade, several devices were approved either as over-the-counter devices or required lesser physician interaction making it necessary to have labels and instructions that can be understood by those not trained in medical practice. Medical device patient labeling come in many forms such as brochures, user manuals, video or audio instructions which could be available as print or online media. They are intended to help a patient or lay caregiver understand how to use the device properly without much discussion with a doctor. Since the first FDA guidance on medical device patient labeling, released in 2001, the industry has come a long way. With increased sophistication of non-supervised devices, FDA has been worried if the current processes are adequate. Also, there is concern that there is no universal format for all similar devices leading to variation in labels from different manufacturers and the associated confusion to the patients. The medical device industry on the other hand does not agree that the current system is flawed and that it needs improvement. The Agency is still forging ahead with its desire the reign in the medical device labeling issue. Last week FDA announced a public meeting to discuss the current practices, specific patient needs, and possible ways to improve the medical devices patient labeling. The discussion is obviously not going away. This does not immediately affect the manufacturers of applicable medical devices but in the current scenario of direct-to-patient marketing of sophisticated devices, particularly home use devices for monitoring health, self-diagnostic kits, genetic diagnostic kits, and 3D printing technology that may evolve into patient-designed medical devices using public information, this is an important discussion that we all need to participate in and contribute to. We will keep an eye on it for our readers.

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research