FDA Related News

Medical Devices

FDA, CMS Reiterate Need for FDA Test Oversight

FDA and CMS officials call for support of an FDA proposal to regulate laboratory-developed tests.

Federal Register

IRB Waiver Info Collection Approved

Federal Register notice: OMB approves an information collection entitled Institutional Review Board Waiver or Alteration of Informed Consent for Minim...

SCOTUS May Tighten Chevron Deference: Attorneys

Two Axinn attorneys say there will be a flood of cases challenging federal agency decisions and interpretations of law if the Supreme Court restricts ...

Medical Devices

CDRH Sets Marketing Authorization Record

The CDRH 2023 annual report says the Center approved the most novel devices in its history.

Human Drugs

U.S. Reassures Canada on Drug Imports

Canada health minister Mark Holland says he has been assured by top U.S. officials that the U.S. does not intend to harm Canadas drug supply by approv...

Medical Devices

IVD Director Timothy Stenzel Retires

CDRH Office of In Vitro Diagnostics director Timothy Stenzel retires after almost six years as head of diagnostic devices.

Medical Devices

Megadyne Mega Soft Electrode Recall is Class 1

FDA says the Megadyne recall of four models of patient return electrodes following reports of patient burns is Class 1.

Medical Devices

GAO Probing FDA Ventilator Recall Actions

The Pittsburgh Post-Gazette says GAO has accepted a request from two senators to look into FDA oversight of medical device adverse events and recalls.

Medical Devices

Reducing the Potential for Pulse Oximeter Bias

Two stakeholders raise concerns about an FDA discussion paper on guidelines for pulse oximeters that consider skin pigmentation, race, and ethnicity.

FDA Needs Help in Regulating Algorithms: Califf

FDA commissioner Robert Califf says FDA needs to work within a community of organizations assessing and evaluating artificial intelligence adaptive to...