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  • hmp42 replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls 8 years, 5 months ago

    Good Discussion so far. A legacy device is one that incorporated a drug before combination product regulations arrived. Many medical device manufacturers have mistakenly assumed that since legacy products were initially reviewed by Centers for Devices and Radiological Health (CDRH), but for combination products that is not true. Developing combination products requires expertise from engineers and pharmaceutical scientists to develop combination products. It is time consuming at the same time. Some combination products examples are,

    Drug Delivery
    • Implantable drug pumps
    • Transdermal Patches
    • Metered dose Inhalers
    • Antimicrobial urinary catheters
    • Eye drops for glaucoma

    Orthopedic and Dental
    • Antibiotic Bone cements
    • Woundcare
    • Antimicrobial dressings
    • Steroid-containing Creams
    • Antimicrobial impregnated Sutures

    Vascular
    • Drug coated balloon catheters
    • Coated vascular prostheses