title: New FDA draft guidance on premarket submissions.
abstract: The United States Food and Drug Administration (FDA) has issued a draft guidance document on the type of quality system information to be included in various premarket submissions. This is the same information that should be maintained at the manufacturing facility for devices subject to the premarket notification or 510(k) process. This article discusses the contents of the draft guidance and recommends that manufacturers send their comments on the guidance to FDA.
authors.affiliation: Donawa and Associates, Ltd., Rome, Italy.
authors.forename: M E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D018795:Device Approval; D004867:Equipment Design; D004864:Equipment and Supplies / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*