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 ...
On September 26, 2017, the Food and Drug Administration (FDA) announced the availability of a final guidance entitled Classification of Products as Drugs and Devices & Additional Product ...
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 U.S. Court of Appeals for the D.C. Circuit recently decided in Genus Medical Technologies LLC v. U.S. Food and Drug Administration that, when classifying a biomedical product as either a “drug” or ...
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 ...
New Delhi: The nodal licensing and regulatory body for medical devices, CDSCO, has issued the draft list of revised risk-based classification of devices in the cardiovascular and neurological domains ...
In a significant move aimed at strengthening regulatory clarity for cancer related medical technologies, the Central Drugs ...
The China Food and Drug Administration (CFDA) recently announced revisions to the Medical Device Classification Catalogue, marking its first update in 15 years. The new catalogue, which will come into ...
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