Medical device companies must, by law, meet certain requirements before marketing a new or substantially modified (physically or in labeled/intended use) device. For any device, except the most benign (generally Class I) or the newest technology (generally Class III), this means the manufacturer or specification developer must seek regulatory clearance for any new or substantially changed device prior to marketing by means of a Premarket Notification, or 510(k), submission.

Medical products manufactured in the United States for sale in the U.S., or manufactured outside the U.S. and shipped into the U.S. for sale in the U.S., and meeting the definition of a device under section 201(h) of the Federal Food, Drug and Cosmetic Act (FD&C Act, or “the Act”) are regulated by the U. S. Food and Drug Administration (FDA). Medical devices are subject to general controls and other controls in the FD&C Act. General controls of the FD&C Act are the baseline requirements that apply to all medical device manufacturers. Unless specifically exempted, medical devices must be:

       • Properly labeled and packaged;

       • Cleared for marketing by the FDA;

       • Consistent in meeting their labeling (intended

           use) claims; and

       • Manufactured under GMPs (Good Manufacturing

           Practices, now known as the new Quality

           System Regulation, a mandated quality

           assurance system).

   The FDA regulates devices to assure their safety and effectiveness. To fulfill provisions of the Act, FDA develops and promulgates rules to regulate devices intended for human use. These rules regulate various aspects of the design, clinical evaluation (where required), manufacturing, packaging, labeling (including promotional information), commercial distribution, and post-market surveillance of devices. These regulations are published in the Federal Register. Final regulations are codified annually in the Code of Federal Regulations (CFR). Most device regulations are in Title 21 CFR Parts 800 to 1299.

   The definition of a device appears in section 201(h) of the Act (not the CFR). A device is “...an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component, part, or accessory, which is:

       • Recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

       • Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

       • Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes…”

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