Becker's ASC

FDA contemplates changing approval process for software used as a medical device — 4 insights

The FDA is contemplating changing its medical device for software approval process, JD Supra reports. Here’s what you should know. 1. Software as a medical device applies to all software used to ...
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Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

Mobile Medical Device Apps and the FDA Training Webinar: Classification, Regulatory Requirements and Cybersecurity

The burgeoning field of Software as a Medical Device (SaMD) offers opportunities for innovation in healthcare monitoring and delivery through mobile apps. Regulatory focus by the FDA on "device ...
Law

AI in Software as Medical Devices (SaMD): Navigating Patent and Regulatory Challenges in the US, Europe

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...
JD Supra

From Vulnerability to Violation: FDA Cybersecurity Requirements for Medical Devices and FCA Enforcement

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System ...
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 ...
MobiHealthNews

Commentary: Why FDA’s software precertification program may be bad for business

So through the adoption of this program FDA hopes to raise the Culture of Quality and Organizational Excellence at medical device software companies. That’s part of what FDA gets out of this, and ...
Medical Device and Diagnostic Industry (MD+DI)

Software Version Control for Medical Devices: Turning Traceability into Compliance Confidence

Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...
FierceBiotech

FDA formally kicks off medical device user fee negotiations

The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and ...
Hosted on MSN

FDA seeks industry feedback on AI medical device safety monitoring

The US Food and Drug Administration (FDA) is seeking industry comment on practical approaches towards measuring and evaluating the performance of AI-enabled medical devices in the real world. With a ...
STAT

Jeff Shuren stabilized the FDA’s medical devices center, winning over industry but not all patients

Retirements from the Food and Drug Administration are hardly shocking, especially in the wake of pandemic burnout. But when longtime medical device director Jeff Shuren announced his departure in July ...