FDA Related News

Medical Devices

FDA Weighing Certification of AI Devices That Learn: Report

Roll Call tells how FDA is working to certify medical devices that use artificial intelligence to learn and evolve.

Federal Register

Final Guide on Fluoroscopic Equipment Requirements

Federal Register notice: FDA makes available a final guidance entitled Policy Clarification for Certain Fluoroscopic Equipment Requirements.

Drug, Medical Device Recalls Down

The Stericycle 2019 Q1 Recall Index shows both pharmaceutical and medical device recalls decreased in the quarter, although Class 1 recalls remain hig...

Human Drugs

CGMP Issues in Laboratoires Clarins Inspection

FDA warns Frances Laboratoires Clarins about CGMP violations in its manufacturing of finished pharmaceuticals.

Medical Devices

Organ Preservation Device Animal Study Guidance

FDA issues a final guidance on best practices for using animal studies to evaluate organ preservation devices.

Medical Devices

Alert on Medtronic Pacemakers Due to Battery Drainage

FDA issues a safety alert on certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers about issues that may cause thei...

Federal Register

Laser Illuminated Projectors Requirements Guidance

Federal Register notice: FDA makes available a final guidance entitled Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser ...

Federal Register

Laser Conformance with IEC Standards Guide

Federal Register notice: FDA makes available a final guidance entitled Laser Products Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1(L...

Federal Register

X-Ray Imaging Devices Conformance Guide

Federal Register notice: FDA makes available a final guidance entitled Medical X-Ray Imaging Devices Conformance with IEC Standards.

Marketing

DTC Accelerated Approval Disclosure Study

The CDER Office of Prescription Drug Promotion proposes a study of accelerated approval disclosure used in direct-to-consumer promotional materials fo...