6 results

• Medical Device Manufacturers Often Fail To Submit Timely Adverse Event Reports to FDA: Study

  March 19, 2025

  Martha Garcia

  The findings of a new study indicate that medical device manufacturers turn in a third of all adverse patient event reports later than legally required.

• FDA Report Details How Agency Made Medical Devices Safer in 2023

  April 22, 2024

  Martha Garcia

  An FDA report highlights improvements in medical device recalls, post-marketing surveillance and manufacturing quality in 2023.

• Following Philips CPAP Recall Failures, U.S. Senators Seek Probe into FDA Medical Device Oversight

  December 15, 2023

  Irvin Jackson

  Two U.S. senators are calling for an investigation into how the FDA handles medical device recalls in the wake of its failures involving Philips CPAP sleep apnea machines.

• Medical Device Deaths Likely Undercounted By FDA, Study Warns

  July 29, 2021

  Russell Maas

  Medical device manufacturers often fail to report patient deaths as deaths, distorting the FDA's view on the safety profile of those devices, which could continue to put patients at risk, according to the findings of a new study.

• FDA Hearing To Discuss When And How It Issues Medical Device Safety Communications

  January 29, 2020

  Russell Maas

  The FDA is holding a public hearing on April 1 to discuss potential ways it can improve medical device safety warnings and recalls.

• The Implant Files: International Investigation Exposes Rampant Safety Problems With Medical Devices

  November 29, 2018

  Irvin Jackson

  A worldwide investigation raises concerns about the state of medical devices, how they are approved, and what happens when they are deemed to be unsafe.