Abstract
There are two primary pathways to gain approval to market a medical device in the US, 510 (k) notification and pre-market approval (PMA). These processes were introduced in chapter 1 (see section 1.6.1). 510 (k) notification involves marketing a device that is substantially equivalent to a device on the market prior to 1976.
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© 1994 Springer Science+Business Media Dordrecht
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Silver, F.H. (1994). 510 (k) and PMA Regulatory Filings in The US. In: Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-0735-8_9
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DOI: https://doi.org/10.1007/978-94-011-0735-8_9
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-010-4316-8
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