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The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section 226) of 2007.
In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) expanded the FDA's authorities and strengthened the Agency's ability to safeguard and advance public health. Among other authorities, FDASIA permitted FDA to publish regulations establishing a Unique Device Identification (UDI) system for medical devices.
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It makes changes to medical device fees, including establishing a fee for a 30-day notice, a request for classification information, and periodic reporting for a class III device. It extends the authority of accredited people (third parties) to review premarket reports for devices and make recommendations to the FDA regarding the classification ...
Uniform Driver Interface, a project to develop portable device drivers; Unified Display Interface, digital video interface specification based on DVI; Universal Disk Image, a disk image format; Unique Device Identification, a system that is intended to assign a unique identifier to medical devices within the United States
The 800 series are for medical devices: 803 Medical device reporting; 814 Premarket approval of medical devices [3] 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) [4] 860 et seq. Listing of specific approved devices and how they are classified; The 900 series covers mammography quality requirements enforced ...
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