title: Regulatory affairs as they affect invasive cardiology.
abstract: Over the last several years, the United States Food and Drug Administration (FDA) has significantly improved the time required for the approval of PMA and PMA supplement applications. By the year 1999, the average approval time for PMA applications was 12 months and the average approval time for PMA supplements was only 4 months. In spite of this improved performance by the FDA, it is still advantageous for many products to have their first clinical trial outside the United States.
authors.affiliation: IsoStent, Inc., 14600 Viburnum Drive, Dayton, Maryland 21036, USA.
authors.forename: R E
authors.initials: RE
authors.lastname: Fischell
mesh_terms: D002309:Cardiology; D018795:Device Approval / Q000331:legislation & jurisprudence; D006801:Humans; D013995:Time; D014481:United States; D014486:United States Food and Drug Administration