Regulatory Affairs Professionals Society

FDA warns device maker, contract testing lab for GMP violations

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...
Medical Design & Outsourcing

FDA removes pediatric VADs from device shortage list, adds others

The FDA has removed pediatric ventricular assist bypass devices (VADs) from its device shortage list in an update this month.
FedTech Magazine

FDA Tightens Its Medical Device Cybersecurity Guidance

Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.
Regulatory Affairs Professionals Society

This Week at FDA: Reactions to FDA’s Bayesian methods guidance, GDUFA science report, and ...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, ...
Yahoo

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 ...
Seeking Alpha

Nearly a third of FDA medical device adverse events reported late: study

Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most late reports filed more than six months after manufacturer notifications, ...
KCCI Des Moines

FDA moves to rehire medical device staffers fired only days earlier

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 night, FDA ...

What Medical Device Companies Need to Know About DOJ Enforcement

Opinion: Medical device companies can create a competitive advantage by leveraging data to strengthen compliance programs and by ensuring effective oversight of quality and regulatory reporting ...