by Brendan Bradley | 4/21/2023
Manufacturers of DTC wearables have begun to seek blended device approval, gaining FDA clearance for certain features within their devices without going through the lengthier process of seeking complete clearance or approval of the entire device. Whether or not a consumer wearable requires any level of FDA regulation depends on its intended use. General wellness products, such as step counters or fitness trackers, are outside the scope of FDA regulation. However, when devices begin to make claims of diagnosing, monitoring, or treating medical conditions, they fall under the definition of a medical device. Based on the similarity to existing products that have already been cleared or approved, and the risk posed to the patient, devices must go through either the less intensive 501(k) clearance process, or the stricter Premarket Approval process.
Apple Watch’s heart monitoring system began as a simple heartbeat sensor and pulse detector in its earliest stages, allowing fitness users to track their cardiovascular output. However, the company quickly saw value in its use as a monitoring device for individuals with irregular heart conditions such as atrial fibrillation, or AFib. Apple led the consumer wearable foray into FDA territory in 2018, when the Apple Watch Series 4’s embedded electrocardiogram (ECG) achieved clearance from the FDA. The AFib History feature, a feature introduced in watchOS 9, received 510(k) clearance from the FDA in 2022 for use by individuals aged 22 or older. This feature will track and send detailed weekly summaries of AFib activity to patients that have already been diagnosed with AFib, offering them insights into how their daily activities impact their health condition. Fitbit, acquired by Google in early 2021, followed a similar staggered clearance path, with its Sense smartwatch’s ECG feature being cleared in 2020, and its passive AFib monitoring system reaching clearance in 2022. While consumer wearables have not yet ventured into the high-risk levels that may require complete FDA approval, increasing exposure to regulatory processes has companies well-positioned to do so. Depending on its intended use and capabilities, the leaked project by Apple’s secretive XDG development team to bring photonic-based continuous glucose monitoring (CGM) to the Apple Watch may require full FDA approval. As competition within the medical wearable market increases, manufacturers may be pushed closer and closer to the most stringent of FDA regulations in order to differentiate with advanced capabilities.
FDA Approval & Embedded Software Solutions
Key to developing these products will be ensuring different levels of FDA regulation are met as needed, and requirements are communicated to all relevant stakeholders during the development process. Product Lifecycle Platforms (PLM) from leading vendors have the ability to align project goals with these stringent and ever-changing standards. The Siemens Quality Package, an add-on to its embedded Linux distributions Sokol Flex OS and Sokol Omni OS, was the first software documentation package designed specifically for medical device OEMs. This service maps the development process to UL 2900, ISO 13458, IEC 62304, and a variety of other industry standards for connected medical devices, ensuring that device development adheres to regulation at all stages. Jama Connect provides useful features for manufacturers of medical devices, adhering to FDA 12 CFR Part 11 and providing the traceability necessary to provide regulators with transparency throughout the development process. Verification & Validation solutions from leading vendors such as Synopsys and Cadence can also help manufacturers adhere to FDA Design Controls.
To learn more about the role of requirements management solutions in safety-critical industries, check out VDC’s new report, The Global Market for Requirements Management & Definition Tools.