Efforts are accelerating by regulators to move more medical products into the homes of patients, citing rising chronic disease rates, provider shortages, and growing strain on the healthcare system, a top US Food and Drug Administration (FDA) official says.
Michelle Tarver, Director of the FDA’s Center for Devices and Radiological Health (CDRH), said the agency is preparing for a shift in care delivery as new technologies allow patients to monitor and manage conditions outside traditional clinical settings.
“Many patients have to drive a hundred miles or more to see a healthcare provider,” Tarver said. “By looking at ways in which we can deliver care in the home more effectively, we may help mitigate these poor outcomes.”
She added that the agency views the effort as forward-thinking. “We are looking at this initiative as a preparatory step for the incoming deluge that we think is going to happen within healthcare,” Tarver said on April 24 at MedCon 2026 in Columbus, Ohio.
“Our focus remains on being a force multiplier for timely access to safe, effective, and high-quality devices.” – Michelle Tarver
The FDA’s home health initiative comes in response to the roughly 40% of adults and one in five children in the US who live with chronic conditions, Tarver said. She further pointed out that a significant share of the clinical workforce is expected to leave their professions in coming years.
At the same time, the agency is managing a surge in medical device innovation. CDRH authorized 124 novel devices in 2025 – one of the highest totals in the center’s history – while overseeing more than 260,000 devices and 25,000 manufacturing facilities.
“Each year, we receive tens of thousands of submissions spanning a wide range of technologies,” Tarver said of the scope of the agency’s workload.
Recent approvals include the first blood test to aid in diagnosing Alzheimer’s disease, along with a growing number of at-home technologies for mental health treatment, cancer screening, and kidney monitoring. And over the past decade, the FDA has cleared more than 400 over-the-counter and home-use diagnostic tests, reflecting the broader shift toward decentralized care.
“Together, these authorizations [and clearances] highlight both the pace and the impact of innovation,” Tarver said.
FDA Eyes Faster Safety Alerts; DHCoE Expansion
As innovation accelerates, the FDA is updating how it regulates and monitors devices, particularly those that are software-driven or -connected. A newly implemented “Early Alert” initiative is designed to notify the public more quickly about potentially high-risk device issues.
“This program puts patients first,” Tarver said. “It lets them know when there’s a challenge and it prompts us to work quickly to mitigate those challenges. Timely communication about safety concerns is critically important.”
The FDA is also expanding its Digital Health Center of Excellence (DHCoE) and offering new tools for developers, including early consultation meetings. “It’s like a show-and-tell,” Tarver said, adding that the agency is working to make its resources more accessible. “It gives us the opportunity to ask important questions prior to the actual regulatory submission.”
Focus on Patients and Public Trust
Across its efforts, the FDA is aiming to balance faster access to new technologies with strong safety oversight and public transparency.
“Patients are at the center of everything we do,” Tarver said. “They are the ultimate recipients of the quality of work that we do.”
She added that the agency’s broader mission remains constant: “Our focus remains on being a force multiplier for timely access to safe, effective, and high-quality devices.”
