Regulatory pathways to the market: an overview
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Updated: Aug 10, 2026

Using SCOPE to Identify Potential Regulatory Motifs in Coregulated Genes
Published on: May 31, 2011
Abstract:
This paper presents an overview of the U.S. Food and Drug Administration's regulatory requirements for introducing medical device and diagnostic products into commercial distribution in the United States. For any specific product, the requirements vary depending upon the product's associated risks, classification, and when it or a similar product was first introduced into commercial distribution. Regulatory pathways available and/or required for a manufacturer to introduce a medical product into the U.S. marketplace are outlined.
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