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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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's Center for Devices and Radiological Health (CDRH) issued a request for public comment on December 5, 2025, seeking feedback on the distinct classification of existing medical device accessories ...

DUBLIN--(BUSINESS WIRE)--The "Medical Device Market, by Device Type, Function, Durability, Therapeutic Segment, Risk Classification, Manufacture Method, Delivery/Acquisition, Operational Support Model ...