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Section 510(k) of the FD&C Act requires manufacturers of these devices to notify FDA of their intent to market a medical device at least 90 days in advance of doing so

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[DOI] [PMC free article] [PubMed] [Google Scholar] 196.Boohaker R.J., Lee M.W., Vishnubhotla P., Perez J.M., Khaled A.R