FDA investigation of WHOOP poses difficulties for specialized wearable device manufacturers

Specialized fitness-tracking brands like WHOOP are now facing heightened regulatory attention as the line between consumer wearables and medical devices becomes increasingly blurred. This shift exposes these companies to higher compliance costs and may weaken their competitive edge.

While the U.S. Food and Drug Administration (FDA) has historically overseen certain health-oriented features in wearables such as smartwatches, many companies have leveraged a "regulatory gray area" to offer tools like blood pressure monitoring within wellness apps without formal approvals.

However, the FDA is signaling stricter enforcement, indicating that functionalities like blood pressure tracking can influence health management decisions and therefore require official clearance.

Rising Costs and Development Hurdles

New regulatory expectations could force wearable manufacturers to invest more in clinical and cybersecurity testing, upgrade quality-management systems, redesign hardware or software, and undergo third-party audits. These requirements may increase research and development expenses and delay product launches for smaller players like WHOOP in the rapidly expanding $90 billion wearables market.

"What was once a boom of health-tech innovation is now encountering regulatory oversight," said Michael Ashley Schulman, chief investment officer at Running Point Capital. Companies must either scale back their features or comply with regulation, which may slow innovation and strain budgets. Features such as blood-oxygen estimation and heart-rhythm monitoring have pushed startups closer to making medical claims.

WHOOP Faces FDA Scrutiny

WHOOP has already received warnings from the FDA. In July, the agency noted that the companys blood pressure insights feature positioned the device more like a medical tool, as it provided estimates of systolic and diastolic values relevant to diagnosing hypertension.

WHOOP maintains that the feature is intended for wellness purposes, helping users understand interactions between blood pressure, sleep, stress, exercise, and overall performance, rather than diagnosing or treating medical conditions.

In contrast, Apple has pursued FDA clearance for its smartwatchs recent hypertension alert feature, which does not diagnose or treat hypertension. This approach could set a regulatory precedent, according to Ricky Bloomfield, medical chief at Oura, a sleep-tracking ring company.

Josep Sola, co-founder of Hilo, a blood pressure wristband company, noted that obtaining approvals took years. Adding unverified clinical features is risky, likened to converting a car into a boat without proper testing. Dr. Francisco Jimenez-Lopez of Mayo Clinic emphasized that inaccurate readings could mislead users, potentially leading to serious health consequences.

Lengthy Approval Process

The wearable health market is growing rapidly, with eMarketer projecting that roughly 83.2 million Americansabout 25% of the populationwill use health-related wearables monthly this year. Yet, obtaining FDA approval can take 90 to 150 days, not including clinical trials, data validation, and documentation. Smaller companies may also need to hire regulatory specialists, which represents a minor cost for giants like Apple or Samsung but can be significant for startups.

In September, the FDA issued broader warnings about the risks of unapproved devices. The agency can enforce compliance through warning letters, injunctions, or product seizures if violations are not corrected.

Author: Olivia Parker