title: US manufacturing guideline for IVD products.
abstract: Non-US manufacturers marketing in vitro diagnostic (IVD) products in the United States (US) or planning to do so should be aware of a US Food and Drug Administration (FDA) manufacturing guideline. Although it needs to be updated to include design controls and a few other requirements in the current Quality System Regulation, it provides useful information on FDA's position regarding the manufacture of these products.
authors.affiliation: Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
authors.forename: M
authors.initials: M
authors.lastname: Donawa
mesh_terms: D018795:Device Approval / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D066298:In Vitro Techniques; D007221:Industry / Q000592:standards*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011933:Reagent Kits, Diagnostic