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 ...
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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 ...
The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical ...
When I was writing last month’s column about former CDRH engineer Leroy Hamilton’s down-the-rabbit-hole quest for a better Form FDA-3429 for guiding device classifications at CDRH, I had no way of ...
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 ...
Please provide your email address to receive an email when new articles are posted on . The FDA announced orthopedic surgical instrumentation designed for osteochondral implants with press-fit ...
The Central Drugs Standard Control Organisation (CDSCO) has announced risk classification of 119 medical devices pertaining to radiotherapy under the Medical Devices Rules (MDR), 2017, as part of ...
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