Serious issues with Medtronic’s nerve monitoring system and Smiths Medical’s ambulatory infusion pumps have prompted software corrections from the two devicemakers, with the FDA assigning the recalls the greatest level of concern. Read More

Sponsors of adaptive AI-enabled medical devices seeking FDA approval should consider submitting a predetermined change control plan (PCCP), according to regulatory attorney Eric Henry of King & Spalding. Read More

CDRH has developed a discussion paper, “Health Equity for Medical Devices,” to gather input from the public on advancing health equity in the context of medical devices. Read More

This excerpt is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The presenter was David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. Read More

With the House and Senate now in recess until Sept. 9, the FDA is once again facing into a new fiscal year unsure of its funding from Congress. Read More

During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More

The FDA has approved Guardant’s Shield blood test for colorectal cancer (CRC) screening in adults aged 45 and older who are at average risk for the disease. Read More

This week, the FDA published notice of user fee rates for fiscal year 2025. Read More

Manufacturers of drugs, biologics and medical devices should be harnessing real-world data (RWD) at the postmarket stage, not just to support regulatory compliance but to generate ideas for innovative new products or indications, according to a former FDA official. Read More

Wayne Pines, senior director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, provides his perspective on the likely direction of health product policies after the presidential election in November. Read More

AMCO International Manufacturing & Design received an FDA Warning Letter because automated external defibrillator (AED) replacement batteries made by the firm have not received FDA approval. Read More

In this edition of Quick Notes, Abbott’s correction for Freestyle Libre 3 sensors, a new FDA webpage for LDTs, 510(k) clearance for Imperative Care catheters and eCential Robotics’ clearance for spine navigation and robotic-assistance device. Read More