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  2. Unique Device Identification - Wikipedia

    en.wikipedia.org/wiki/Unique_Device_Identification

    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 .

  3. FDA Releases Final Rule for Unique Device Identification - AOL

    www.aol.com/2013/09/23/fda-releases-final-rule...

    FDA Releases Final Rule for Unique Device Identification Final Rule Represents Significant Industry Shift to Use UDIs DELRAY BEACH, Fla.--(BUSINESS WIRE)-- Digital Angel Corporation ("Digital ...

  4. FDA Center for Devices and Radiological Health - Wikipedia

    en.wikipedia.org/wiki/FDA_Center_for_Devices_and...

    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.

  5. FDA Rule Mandating Unique Device Identification for Reusable ...

    www.aol.com/news/2013-09-30-fda-rule-mandating...

    FDA Rule Mandating Unique Device Identification for Reusable Medical Devices Creates New Market Opportunity for VeriTeQ in Breast Implant Sizers and Other Reprocessed Devices Company estimates ...

  6. Food and Drug Administration Amendments Act of 2007

    en.wikipedia.org/wiki/Food_and_Drug...

    It requires the FDA to submit an annual report to congressional committees that includes: (1) the number of devices approved in the preceding year for which there is a pediatric subpopulation that suffers from the disease; (2) the number of approved devices labeled for use in pediatric patients; (3) the number of fee-exempt devices approved ...

  7. Medical Device Regulation Act - Wikipedia

    en.wikipedia.org/wiki/Medical_Device_Regulation_Act

    Medical device cannot be classified as a class I device because the controls authorized are insufficient to provide reasonable assurance of the safety and effectiveness of the device. Medical device has sufficient information to establish a performance standard and it is necessary to establish a performance standard for the device.

  8. Validation and verification (medical devices) - Wikipedia

    en.wikipedia.org/wiki/Validation_and...

    For instance, a regulatory agency (such as CE or FDA) may ensure that a product has been validated for general use before approval. An individual laboratory that introduces such an approved medical device may then not need to perform their own validation, but generally still need to perform verification to ensure that the device works correctly ...

  9. Global Medical Device Nomenclature - Wikipedia

    en.wikipedia.org/wiki/Global_Medical_Device...

    Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.