Abstract
Medical devices and medical disposables contribute significantly to the quality and effectiveness of the health care system. It is necessary to commit scientifically sound regulatory environment that will provide consumers with the best medical care. This includes continued services to small manufacturers, readily available guidance on FDA requirements, predictable and reasonable response times on applications for marketing, and equitable enforcement. But in the public interest, this commitment to the industry must be coupled with a reciprocal commitment: that medical device firms will meet high standards in the design, manufacture, and evaluation of their products. The protections afforded our consumer, and the benefits provided the medical device industry, cannot be underestimated.
Highlights
Medical devices are an extraordinarily heterogeneous category of products
Medical devices range from wound dressings to artificial hearts, designed to support life in many end-stage cardiac patients
Polymers originally designed for commercial applications were adapted for implantable prostheses, opening the way for pacemakers, vascular grafts, synthetic wound dressings that mimic intact human skin, and a variety of artificial organs (1)
Summary
Medical devices are an extraordinarily heterogeneous category of products. The term "medical device" includes technologically simple articles such as hypodermic syringes and blood bags. - collecting and monitoring adverse effects from marketed products and investigations, and taking action, when necessary, to prevent injury or death; The process provides for orderly development of new devices starting with bench and animal tests, moving through scientifically sound clinical investigations, and, only after independent review of the results, approval for marketing. (2) to provide early feedback in order to detect and fix design or manufacturing flaws; and (3) to give doctors and patients an accurate interpretable experience from which to determine in whom to use a device, what to expect from its use, and how to avoid a prolonged learning curve using it (so that patients benefit)
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