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Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...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 ...
JD Supra

Drug and Medical Device Regulation Under the Trump Administration

Many of President Trump’s executive orders (EOs) and legislative measures have been designed to curtail federal regulation, reduce the size of the administrative state, and withdraw the U.S. from ...
MD&M East

Embrace FDA Regulations: Turn Medtech Compliance Into Your Competitive Edge

Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...
Forbes

FDA Medical Device Cybersecurity And SBOMs: Compliance And Potential

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
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 ...

Philips Had Received Warning Letter From FDA on Medical Device Facilities

The letter, dated Sept. 9, was issued by the Center for Devices and Radiological Health. It follows inspections of Philips Ultrasound facilities in Bothell, Wash. and Reedsville, Pa., as well as a ...
Hosted on MSN

FDA scraps ‘Final Rule’ classifying LDTs as medical devices

The US Food and Drug Administration (FDA) has chosen to axe its ‘Final Rule’ from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of ...
Becker's ASC

Colorado Senator: FDA Device Reforms Should Simplify Process

U.S. Senator Michael Bennet (D-Colorado) is urging the FDA to choose medical device regulatory reforms that will simplify manufacturing processes, according to a news release from Sen. Bennet. In a ...

Arctx Medical Receives FDA Marketing Authorization for its Arctx Cool Catheter(TM) Set for Body Temperature Regulation, Releases Initial Clinical Results in Acute Pancreatitis

Arctx Medical, Inc. ("Arctx, " "the Company"), a clinical-stage medical device company, announced today that it has achieved two additional significant milestones: Arctx was granted FDA 510(k) ...