New routes to the United States: special and abbreviated 510(k)s.
Special and Abbreviated 510(k)s are two new approaches to obtaining clearance for medical devices to be marketed in the United States (US) that are designed to streamline the traditional 510(k) review process. This article answers commonly asked questions relating to the requirements for these types of 510(k)s, preparation of applications, and how the US Food and Drug Administration handles these submissions.
Nolte
C J
CJ
Medical Device Consultants Inc., Raleigh, North Carolina, USA. nolte@mdci.com
McNamara-Cullinane
M
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D018795:Device Approval; D004869:Equipment Safety; D006801:Humans; D011640:Public Policy; D017748:Time Management; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards