Diagnostics and medtech.
In vitro diagnostics are regulated as medical devices under different instruments in the US and EU: FDA classification and premarket review in America, and the dedicated European Regulation 2017/746 in Europe. The US boundary moved in 2025, when a federal court vacated the FDA's…
Medical device trials run on an Investigational Device Exemption, the instrument that "allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data," per FDA — and all such evaluations, unless exempt, "must have an approved IDE before the…
AI-enabled medical imaging devices are regulated as medical devices whose software uses artificial intelligence, authorized through FDA's existing premarket pathways and tracked on the public AI-Enabled Medical Device List. The list exists, per FDA, to identify AI-enabled devices authorized for…
The FDA's Quality Management System Regulation took effect on February 2, 2026, replacing the Quality System Regulation that US device manufacturers have operated under since 1996. The new rule amends the device current good manufacturing practice requirements of 21 CFR Part 820 by incorporating…
Wearable health devices are regulated by where their claims sit on a line FDA draws between lifestyle encouragement and disease-related intervention: general wellness products fall outside device regulation, while claims to detect or inform clinical management require a premarket pathway. The…
Point-of-care testing is diagnostic testing performed at or near the patient, in a physician's office, clinic, or emergency room, rather than a central laboratory, and its legal boundary in the United States is set by CLIA. The FDA categorizes tests as waived, moderate, or high complexity; only…