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  2. FDA Center for Devices and Radiological Health - Wikipedia

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

    FDA Laboratory Building 62 (Engineering and Physics) houses the Center for Devices and Radiological Health. The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices.

  3. Structured Product Labeling - Wikipedia

    en.wikipedia.org/wiki/Structured_Product_Labeling

    Structured Product Labeling ( SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.

  4. FDA Adverse Event Reporting System - Wikipedia

    en.wikipedia.org/wiki/FDA_Adverse_Event...

    The FDA Adverse Event Reporting System ( FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration 's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might ...

  5. 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 .

  6. Medical device reporting - Wikipedia

    en.wikipedia.org/wiki/Medical_device_reporting

    Medical device reporting ( MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled. Consumers and health professionals report ...

  7. First Databank - Wikipedia

    en.wikipedia.org/wiki/First_Databank

    Website. fdbhealth .com. First Databank ( FDB) is a major provider of drug and medical device databases that help inform healthcare professionals to make decisions. [1] FDB partners with information system developers to deliver useful medication- and medical device-related information to clinicians, business associates, and patients.

  8. Medical Device Regulation Act - Wikipedia

    en.wikipedia.org/wiki/Medical_Device_Regulation_Act

    21 U.S.C. ch. 9, subch. VIII ยง 381. The Medical Device Regulation Act or Medical Device Amendments of 1976 was introduced by the 94th Congress of the United States. Congressman Paul G. Rogers and Senator Edward M. Kennedy were the chairperson sponsors of the medical device amendments.

  9. 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 ; 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) 860 et seq. Listing of specific approved devices and how they are classified; The 900 series covers mammography quality requirements enforced by CDRH.