On May 20, 2021, FDA published a document (“Safety of Metals and Other Materials Used in Medical Devices”) requesting input regarding the best methods to use in conveyance of material information for ...
The world of medical devices is growing more sprawling every day. Some promising novel ideas can take longer to wind their way through regulatory review and get to patients — so since 2017, the Food ...
FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...
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 ...
CDSCO releases risk classification for 119 radiotherapy devices: Gireesh Babu, New Delhi Wednesday, December 3, 2025, 08:00 Hrs [IST] The Central Drugs Standard Control Organisati ...
New Delhi: In an attempt to bring regulatory uniformity in medical devices, the government plans to classify around 1,178 medical devices into four categories based on their risk approach under the ...
Why Cresilon, Audicus, ivWatch, and GrayMatters Health are among Fast Company’s Most Innovative Companies in the medical device category for 2024. Healthcare is the backbone of society, but good ...
The agency also changed some of the categories for the list, which includes the reason the supply is in shortage and gives an estimate on how long the shortage is expected to last. Also included on ...
When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
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