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American Hospital Association

FDA vacates final rule regulating lab-developed tests as medical devices

The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules ...
MobiHealthNews

Q&A: A doctor's opinion on the FDA AI certification process

Dr. Erik Langhoff, chief medical officer and consultant for the Bronx Regional Health Information Organization, discusses how ...
JD Supra

FDA (Finally) Harmonizes Medical Device Manufacturing Requirements With ISO

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...
American Enterprise Institute

Congress Must Update FDA Regulations for Medical AI

The FDA’s firm-based approach to regulating medical devices means that the regulatory oversight focuses on the quality systems and processes of the manufacturing firm, rather than just on the ...
The National Law Review

FDA Final Rule Harmonizes Medical Device Quality System Regulation with International Standard

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

FDA panel to weigh in on AI mental health devices

The U.S. Food and Drug Administration will hold an advisory panel meeting in November to examine the fast-emerging class of ...
Fierce Biotech

Following the Apple Watch's hypertension clearance, FDA warns public against using unauthorized blood pressure tech and baby monitors

The FDA has also granted a de novo clearance to the Snoo motorized bassinet from Happiest Baby, as its first device for ...
JD Supra

Regulation of drug and medical device advertising in China: an industry under the microscope

In recent years, there has been an uptick in interest in the Chinese market from licensors based predominantly in the U.S., Canada, Europe, and South Korea. Factors encouraging the in-licensing of ...
News Medical

Medical Device Categories Explained

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...