MedCity News

Regulatory classification 101: A guide to how your medical device will be classified

What I am about to share with you is a guide to medical device regulatory classification. In this guide, I will provide you with a step-by-step approach for determining how your medical device will be ...
Becker's Hospital Review

FDA cuts 8 software functions from medical device classification

The FDA is excluding eight software functions that were previously classified as medical device status under the 21st Century Cures Act. The FDA released the new provisions in an April 19 document in ...
Healio

FDA releases final rule on classification, reclassification of medical devices

Please provide your email address to receive an email when new articles are posted on . The FDA issued a final rule that implements modifications made by the FDA Safety and Innovation Act, as well as ...
The National Law Review

CFDA Issues New Classification Catalogue for Medical Devices In China

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 ...
UMass Lowell

Demystifying Medical Device Classification & Approval with MITRE 8/19

Medical device startups, are you struggling to understand FDA regulations? Join our webinar with not-for-profit organization MITRE for help. Medical device startups, are you struggling to understand ...
Medscape

FDA Panel Catches Up on Medical Device Classifications

The Gastroenterology and Urology Devices Panel of the US Food and Drug Administration's (FDA's) Medical Devices Advisory Committee deliberated yesterday on the classification of 4 categories of ...
Forbes

The Rise Of Use Of Medical Devices Force FDA To Change The Rules

A disruptive market of $410 billion until 2023, changes dramatically with the entrance of small and medium size players, many of them rising up from the startup community. Software plays a big part in ...
JD Supra

Overview of Medical Device Regulation in China

How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the ...
The National Law Review

Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

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 ...
JD Supra

Devil Is Always in the Details: FDA Updates Device Classification Regulations To Remove Certain Software Functions

On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products.
Seeking Alpha

Spectral AI’s DeepView SnapShot® Wound Imaging System, Achieves UKCA Mark and FDA Class 1 Medical Device Classification

DALLAS, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster ...