FDA recently issued two draft guidance documents intended to reduce oversight for low-risk medical devices: Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types and General Wellness: Policy for Low Risk Devices. To encourage innovation in health IT, FDA proposes to regulate medical device accessories based on the risks they present when used as intended with their parent devices, rather than the risk of the parent device itself. The medical device accessories guidance clarifies that FDA considers "accessories" to be devices intended to augment, supplement, or support another device, and it provides some examples of how FDA would evaluate a device under these criteria. In its general wellness guidance, FDA proposes to not evaluate whether low-risk general wellness products are "devices" as defined in the Food, Drug, and Cosmetic Act or if they are devices, whether they comply with the device requirements. For the purpose of this guidance, the Agency defines "general wellness products" as products that present a very low risk to users' safety and are intended only for "general wellness use." Interestingly, FDA does not state that it is exercising "enforcement discretion," which is the term that the Agency commonly uses to describe its informal decision not to regulate, in whole or in part, a type of product as a device. The guidance clarifies that general wellness use means an intended use that relates to maintaining or encouraging a general state of health or a healthy activity and may reduce the risk or impact of certain diseases or conditions through a healthy lifestyle under certain circumstances. Comments on both guidances are due April 20, 2015.
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