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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 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.

  4. Food and Drug Administration Amendments Act of 2007

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

    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 ...

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

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

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

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

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  7. Title 21 of the Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Title_21_of_the_Code_of...

    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 ...

  8. Regulation (EU) 2017/745 - Wikipedia

    en.wikipedia.org/wiki/Regulation_(EU)_2017/745

    A similar database is the Global Unique Device Identification Database (GUDID) of the FDA. As a key to EUDAMED, the MDR introduces the Basic UDI-DI as unique device identifier. A medical device (including system- and procedure packs and IVD) needs to have an assigned Basic UDI-DI and needs to be registered in the UDI/Device part of EUDAMED.

  9. Design controls - Wikipedia

    en.wikipedia.org/wiki/Design_controls

    The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information ...