Today we posted two draft guidance documents that outline our thinking about low-risk devices intended to promote general wellness and our risk classification approach to medical device accessories. We committed to issuing these guidances in the FDASIA Health IT Report we posted in April 2014.
The FDA is proposing to not enforce regulatory compliance for products that are intended only for general wellness. These products are designed to maintain or encourage a general state of health and may associate a healthy lifestyle with reducing the risk or impact of certain diseases or conditions. We hope this policy fosters the development of low-risk products intended to promote a healthy lifestyle.
We are also proposing to regulate medical device accessories based on the risks they present when used as intended with their parent devices and not based on the risks of their parent devices. For example, if a parent device warrants regulation as a Class II device but an accessory to the parent device presents lower risks, we would regulate the accessory as a Class I rather than a Class II device.
The FDA seeks input on these draft guidance documents from industry and other stakeholders during the comment period for each.
Food and Drug Administration
Center for Devices and Radiological Health