MD&M East

To Be or Not to Be (a Medical Device): FDA Vs. WHOOP

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
MobiHealthNews

FDA reneged on its promise to take a risk-based approach to CDS software

There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. Since the Medical Device Amendments of 1976, a ...
Becker's Hospital Review

FDA expands Early Alert program to all medical devices

The FDA has expanded its Early Alert program to give the healthcare industry earlier visibility into potential high-risk medical device issues. The agency’s Center for Devices and Radiological Health ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...