FDA Related News

Medical Devices

J&J Settles Metal Hip Cases for $1 Billion

Bloomberg Technology reports that Johnson & Johnson is paying $1 billion to resolve most of 6,000 suits involving its Pinnacle metal-on-metal hip impl...

Human Drugs

Comments on Nonproprietary Biologic Naming

Three stakeholders comment on an updated FDA guidance on nonproprietary naming of biological products.

Human Drugs

House Passes 2 Bills on Orange and Purple Books

The House passes two bipartisan bills that would make updates to FDAs Orange Book and Purple Book to improve accuracy and transparency of the two data...

Medical Devices

CryoConcepts Gains Clearance for 2 Cryosurgical Devices

FDA clears two CryoConcepts 510(k)s for two cryosurgical devices for physicians.

Medical Devices

FDA Clears BioCardias Avance Steerable Introducer

FDA clears a BioCardia 510(k) for the Avance steerable introducer, which is designed for introducing various cardiovascular catheters into the heart.

Federal Register

Animal Studies for Organ Preservation Devices Guide

Federal Register notice: FDA makes available a final guidance entitled Utilizing Animal Studies to Evaluate Organ Preservation Devices.

Federal Register

Info Collection Extension on Device e-Registration

Federal Register notice: FDA sends to OMB an information collection extension entitled Electronic Submission of Medical Device Registration and Listin...

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...