US guidance on formatting 510(k)s.
There is no official form for submitting a United States premarket notification or 510(k) submission. A recent Food and Drug Administration guidance document describes the manner in which this type of premarket submission should be formatted. This article discusses this document and so me important aspects of the 510(k) process.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D004282:Documentation; D004864:Equipment and Supplies; D017408:Guidelines as Topic; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*