Compared to other global industries, the medical device industry has some of the highest costs and tightest regulations surrounding its New Product Introduction Process (NPI). NPI refers to the process of taking a novel medical device product from initial concept to the design development stage and through to commercialization. In the United States,
Medical device companies that wish to market a new product in the United States are required to classify their device in terms of the FDA’s medical device classification system, choose the appropriate pre-market submission pathway, establish evidence of device efficacy, submit the appropriate documentation and complete the establishment registration and device listings with the FDA.
FDA describes a five-step premarket process for medical device companies who wish to sell their devices in the United States. As stated in the steps outlined below, this process places stringent regulations on medical device companies to evaluate the risk of their devices and demonstrate with clinical evidence that new products are effective.
Medical device companies must designate their device in one of three risk classes outlined by
Medical device companies must follow the path to regulation that is determined by their device risk classification. An FDA 510(k) submission is appropriate for Class I and Class II devices where the manufacturer intends to demonstrate a substantial equivalence between the new device and a predicate device. A PMA, or premarket approval submission, is required for most of the high-risk Class III devices. New products without a valid predicate may be classified as Class I or Class II if certain criteria
Next, a medical device company must prepare its premarket submission. Premarket submissions require medical device companies to submit clinical evidence that shows their device is safe and effective. Completing clinical trials for an unapproved medical device may require the manufacturer to apply for an Investigational Device Exemption (IDE). Class II and Class III devices must be designed in accordance with FDA design control regulations stated in the FDA quality system regulations (QSR), and any nonclinical testing used to support premarket applications should comply with Good Laboratory Practices (
Once adequate evidence has been collected, medical device companies can then submit their premarket approval documentation to FDA. It is important to communicate clearly and consistently with the FDA during the review process.
Once a medical device company receives premarket approval from
Medical device companies engaged in the New Product Introduction (NPI) Process must support their efforts with the establishment and maintenance of a medical device quality system that promotes quality products and processes while supporting compliance with the FDA QSR.
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