title: Working draft of the FDA GMP final rule (Part I).
abstract: On 24 July 1995, the US Food and Drug Administration (FDA) published a notice of availability of a working draft of a final rule for new good manufacturing practice (GMP) regulations for medical devices. The new regulations could be in force by late 1996. This is the first of a two-part series of articles discussing key provisions of the working draft and their importance to companies marketing or planning to market devices in the US.
authors.affiliation: Donawa and Associates Ltd., Rome, Italy.
authors.forename: M E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D001698:Biomedical Engineering / Q000331:legislation & jurisprudence*; D004867:Equipment Design; D004864:Equipment and Supplies / Q000592:standards*; D017408:Guidelines as Topic; D011050:Policy Making; D014481:United States; D014486:United States Food and Drug Administration