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  2. ISO 10993 - Wikipedia

    en.wikipedia.org/wiki/ISO_10993

    The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. [1]

  3. Notified body - Wikipedia

    en.wikipedia.org/wiki/Notified_Body

    At the same time the NB-MED (European Forum of Notified Bodies Medical Devices) coordination revised their code of conduct due to criticism. [ 7 ] [ 15 ] In late 2013 and early 2014, a French court ordered (and later upheld its decision) that notified body TÜV Rheinland pay restitution to those affected by the PIP scandal. [ 16 ]

  4. Validation and verification (medical devices) - Wikipedia

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

    Standards for validation and verification of medical laboratories are outlined in the international standard ISO 15189, in addition to national and regional regulations. [1] As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device:

  5. FDA Center for Devices and Radiological Health - Wikipedia

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

    Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]

  6. Safe Medical Device Amendments of 1990 - Wikipedia

    en.wikipedia.org/wiki/Safe_Medical_Device...

    The U.S. congressional review concluded medical devices would require actual device experience in a clinical setting and sufficient reporting of adverse data events. The legislation would encompass medical devices demonstrating the potential for life-threatening events and accurate adverse data collection would be required for informed ...

  7. 2010 DePuy Hip Recall - Wikipedia

    en.wikipedia.org/wiki/2010_DePuy_Hip_Recall

    Medical Device Alert: DePuy ASR TM acetabular cups used in hip resurfacing arthroplasty and total hip replacement, Medicines and Healthcare products Regulatory Agency, MDA/2010/044, 25 May 2010 Medical Device Alert: All metal-on-metal (MoM) hip replacements , Medicines and Healthcare products Regulatory Agency , MDA/2012/008, 28 February 2012

  8. Good laboratory practice - Wikipedia

    en.wikipedia.org/wiki/Good_Laboratory_Practice

    These principles exclude studies involving human subjects. Depending on the location or governing rules in an OECD-member country, the OECD Principles of GLP might also extend to non-clinical safety testing of other regulated items, like medical devices. [3] Examples studies conducted under GLP in OECD-member countries include:

  9. Single use medical device reprocessing - Wikipedia

    en.wikipedia.org/wiki/Single_Use_Medical_Device...

    The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...