FDA Law Blog

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

Clinic 59

Clinic Telehealth Provider Electronics 59

FDA Law Blog

DECEMBER 13, 2022

One example is a short provision that could have a large adverse effect on telehealth-based laboratory testing by sharply restricting grandfathering. Telehealth has become increasing important to the health care system. Telehealth can address significant issues with access and convenience. This is not a trivial matter.

Telehealth 72

Telehealth Patients Manufacturing Transportation 72

FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. telemedicine and telehealth solutions (e.g., and remote or wearable patient monitoring devices (e.g.,

Medical 45

Medical Patients Healthcare Electronics 45

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Some members of the Specialty Board were interested in the LKA experience, participant survey results—particularly responses about fairness—and how LKA performance data might reflect on clinical outcomes. The following is a summary of the spring meeting.

Board-Certified 52

Board-Certified Government Community Education 52