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Regulatory Pathways to the Market: An Overview
Author(s) -
Morton William A.
Publication year - 1982
Publication title -
artificial organs
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.684
H-Index - 76
eISSN - 1525-1594
pISSN - 0160-564X
DOI - 10.1111/j.1525-1594.1982.tb04146.x
Subject(s) - food and drug administration , product (mathematics) , risk analysis (engineering) , medical device , distribution (mathematics) , business , new product development , computer science , engineering , marketing , mathematical analysis , geometry , mathematics , biomedical engineering
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.