The FDA said in a draft guidance issued last week that it does not intend to regulate general wellness products, which include an array of consumer-oriented wearables like Fitbit's exercise trackers.
"No longer does the mere mention of a disease in promotional materials [of a general wellness product] mean that FDA may regulate it," attorney Bradley Merrill Thompson of the law Epstein Becker Green, told Health Data Management. "FDA has chosen to draw a very common sense line that avoids regulating products that help people manage common chronic diseases. Those are incredibly important extensions of FDA's policy of enforcement discretion."
But what about wearables that have a more explicit medical function? In a related and concurrently released draft guidance on the classification pathway for new accessory types, the FDA strongly hinted that new medical device accessories can apply for less stringent regulation and approval pathway so that they are more loosely regulated than their parent device.
"Classifying an accessory in the same class as its parent device is appropriate when the accessory, when used as intended, meets the criteria for placement in that class. However, some accessories can have a lower risk profile than that of their parent device and, therefore, may warrant being regulated in a lower class," the agency said in the draft guidance.
This guidance applies to wide array of devices, not just wearables. The FDA defines a medical device accessory as a "device intended to support, supplement, and/or augment the performance of one or more parent devices." Specific examples given include rechargeable batteries, a new balloon catheter used to insert an already approved transcatheter heart valve, and a new guidewire intended for use with a previously approved device.
The FDA classifies devices three ways. Class I devices are generally exempt from premarket notification, while Class II devices require a 510(k) application for approval, and high-risk Class III devices require a stringent PMA application for approval, including clinical trials. The FDA says accessories to Class III parent devices can be regulated as Class II or Class I devices.
However, all new device types--such as accessories that do not have a substantially equivalent predecessor of themselves on the market--are subject to Class III regulations and approval requirements unless they successfully file a de novo application.
The FDA encouraged industry to utilize the de novo approval process, designed to accommodate low-to-moderate-risk devices that do not have a "substantially equivalent" predecessor on the market. The guidance explained the process by which a manufacturer can file a de novo application for a new medical device accessory.
Approval of a medical device accessory under the de novo pathway means that it poses a low to moderate risk and is subject to Class I or Class II requirements. It also means subsequent candidates deemed substantially equivalent to the accessory can apply for approval under the less stringent pathway.
The FDA said smartphones and computer monitors that display information will not automatically be considered medical device accessories.
Thompson wishes the guidance on accessories contained more details, telling Health Data Management, "We also wanted FDA to shed more light on how it regulates claims associated with an accessory, and the required validation by the accessory product manufacturer."
- read the article in Data Health Management