title: Regulatory aspects of invasive glucose measurements.
abstract: On May 26, 1976, the Food and Drug Administration (FDA) began implementing the Medical Device Amendments to the Federal Food Drug and Cosmetic Act. These amendments give FDA specific authority to regulate "medical devices." Additional authority was provided in the Safe Medical Devices Act of 1990. The pathways to get in vitro diagnostic products to market for commercial distribution include: premarket notification [or 510(k)] and premarket approval (PMA). Reviews of these applications are performed in the Division of Clinical Laboratory Devices, Office of Device Evaluation within the Center for Devices and Radiological Health. Most submissions for invasive glucose devices are 510(k) applications. Through this process the manufacturer demonstrates that its device is substantially equivalent to another device that is already legally marketed, referred to as the predicate device. To date, noninvasive and minimally invasive glucose testings have been approved through the PMA process and will be discussed in a separate article.
authors.affiliation: Center for Devices and Radiologic Health, Rockville, Maryland 20855, USA.
authors.forename: Steve
authors.initials: S
authors.lastname: Gutman
authors.forename: Patricia
authors.initials: P
authors.lastname: Bernhardt
authors.forename: Arleen
authors.initials: A
authors.lastname: Pinkos
authors.forename: Marva
authors.initials: M
authors.lastname: Moxey-Mims
authors.forename: Thomas
authors.initials: T
authors.lastname: Knott
authors.forename: Jean
authors.initials: J
authors.lastname: Cooper
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004704:Endocrinology / Q000295:instrumentation* / Q000379:methods; D004864:Equipment and Supplies / Q000592:standards; D033161:Government Regulation; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001786:Blood Glucose