JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
Medical Device and Diagnostic Industry (MD+DI)

Why Small Medtech Companies May Struggle with FDA's New Cybersecurity Rules

FDA Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...
Odessa American

FDA moves to rehire medical device staffers fired only days earlier

WASHINGTON Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning Friday ...
Medical Design & Outsourcing

How listening, learning and leading won FDA de novo classification for Peytant

Peytant Solutions CEO John Schorgl explains how his device startup turned a complex FDA de novo application into a lasting ...
STAT

FDA clears spinal cord stimulator for home use

The FDA has cleared home use of a device that helps people with spinal cord injuries regain mobility and functioning.
JD Supra

FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of ...
MD&M East

How Early FDA Engagement Can Accelerate Medical Device Approval & Reduce Market Delays

At the upcoming MD&M East show in New York City in May, Janet Kwiatkowski, MBA, MSRA, president and CEO of MAE Group, will give a talk entitled “Importance of Early Dialog & Interaction with the FDA.” ...
Becker's Hospital Review

Confidential FDA Medical Device Files Accidentally Leaked Online

The Food and Drug Administration is investigating how a contracted document management company accidentally made public 75,000 pages of confidential FDA files related to approval of medical devices, ...
Hosted on MSN

FDA moves to rehire medical device, food safety and other staffers fired days earlier

WASHINGTON (AP) — Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning ...
Penn Live

FDA rehires medical device staffers fired only days earlier

WASHINGTON (AP) — Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning ...
WSLS 10

FDA moves to rehire medical device, food safety and other staffers fired days earlier

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew Harnik, File) (Andrew Harnik, Copyright ...