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Safety of Metals and Other Materials Used in Medical …

    https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices
    The FDA believes this is an important first step to ensure patients and physicians have access to more comprehensive information on different materials (including but not limited to metal...

Medical Device Sterilization: 4 Alternatives …

    https://www.mddionline.com/sterilization/medical-device-sterilization-4-alternatives-using-ethylene-oxide
    Of those, FDA selected four participants and five submissions: NovaSterilis - supercritical carbon dioxide sterilization (scCO 2 ) Noxilizer - nitrogen …

Substituting medical devices: Lessons from Europe and Morocco

    https://noharm-europe.org/articles/news/europe/substituting-medical-devices-lessons-europe-and-morocco
    Tags: Medical Devices, DEHP, PVC, EDCs, Endocrine disrupting chemicals Medical devices containing PVC are often plasticised with DEHP – a phthalate classified …

Device, Implant, and Skin Substitute Policy, Facility

    https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-reimbursement/COMM-Device-Implant-Skin-Substitute-R5019.pdf
    Device, Implant, and Skin Substitutes with Associated Procedures These coding guidelines will be applied to outpatient hospital services using the CMS criteria for devices, …

National Center for Biotechnology Information

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5620794/
    National Center for Biotechnology Information

Guidance Document for Dura Substitute Devices

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-document-dura-substitute-devices-guidance-industry
    Dura substitutes are class II devices (Panel 84, Procode GXQ) which are described in 21 CFR 882.5910 as "a sheet or material that is used to repair the dura mater (the …

Alternatives to PVC: Medical materials - ScienceDirect

    https://www.sciencedirect.com/science/article/pii/S1369702104000719
    In recent years, there has been increasing environmental concern over the use of poly (vinyl chloride) or PVC materials in the manufacture of medical devices, such …

Alternative Medical Device Definition | Law Insider

    https://www.lawinsider.com/dictionary/alternative-medical-device
    Alternative Medical Device means an alternative medical device, having an equivalent therapeutic use as the relevant Medical Device, that PTAC or its sub- committees, or …

PVC-Free Alternatives | Health Care Without Harm

    https://noharm-uscanada.org/content/europe/pvc-free-alternatives
    Availability of Alternatives Bags: PVC-free bags made of ethylene vinyl acetate (EVA), multilayer polyethylene or polypropylene are cost-effective... Tubing: PVC-free tubing …

Bone Grafts and Substitutes - Medical Devices Pipeline Product ...

    https://www.researchandmarkets.com/reports/5505127/bone-grafts-and-substitutes-medical-devices
    This report features 117 companies, including Element Orthopedics Inc (Inactive), Indian Institute of Technology Bombay, Sanara MedTech Inc, SDIP Innovations Pty Ltd



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