U.S. Food and Drug Administration (FDA)

The FDA is inviting medical device developers to participate in the READI-Home Innovation Challenge, seeking proposed solutions for home-use medical technologies that reduce hospital readmissions, with selected participants receiving direct regulatory feedback to refine their designs.

The FDA has finalized guidance on premarket submission requirements for weight loss medical devices, covering non-clinical testing, clinical study design, and benefit-risk analysis. Developers of intragastric implants, aspiration therapy systems, and neuromodulators will want to review the agency's recommendations closely.

The U.S. Food and Drug Administration has issued updated guidance on cybersecurity requirements for medical device premarket submissions, aligning more closely with current quality management system standards, emphasizing lifecycle risk management, and encouraging manufacturers to adopt secure product development frameworks.

The FDA has refreshed its list of recognized standards, adding new cybersecurity‑focused health‑informatics standards and updated materials tests used in medical devices. The latest changes signal where regulators are heading—and what manufacturers will need to show in future submissions.

New FDA data shows more than 1200 medical devices have now been granted Breakthrough Device designation. With 164 approvals in fiscal year 2025 and continued strong activity across CDRH and CBER, the program remains a key pathway for accelerating innovative medical technologies.

The U.S. Department of Health and Human Services will launch a new study examining potential health effects of cellphone radiation, following the FDA’s removal of older web pages on the topic. The review aims to clarify scientific gaps amid evolving wireless technologies.

Fitness trackers and wellness wearables just got regulatory relief. The FDA's new draft guidance exempts low-risk consumer wellness devices from medical device scrutiny—unless they claim to be "medical grade." Here's what changed and what triggers stricter reviews.

The FDA can't protect patients without knowing shortages are coming. While the EU implemented mandatory device shortage reporting in 2025, the U.S. still has no requirements—leaving pediatric patients especially vulnerable to supply chain disruptions.

The FDA's medical device recall oversight is failing—and staffing shortages are to blame. GAO's December report shows nearly three-quarters of recalls exceeded termination targets during 2020-2024, with congressional recommendations for strategic staffing increases now on the table.

The FDA has updated its lists of medical devices with digital health technologies, including AI-enabled devices, AR/VR medical devices, and sensor-based digital health technology. These FDA-authorized device lists help healthcare providers understand the current digital health landscape and support informed use of advanced medical technologies in patient care.