title: FDA's requirements for in-vitro performance data for prosthetic heart valves.
abstract: The Center for Devices and Radiological Health, Food and Drug Administration, has recently revised its "Replacement Heart Valve Guidance". That document lists the data FDA deems necessary to support the approval of new prosthetic heart valves of all designs, and which should be contained in Premarket Approval Applications for these devices. The Guidance covers detailed data requirements for in vitro, animal, and clinical data. This paper is intended to briefly summarize FDA's requirements for in vitro data, and, for those cases where it may not be obvious, to provide an overview of the significance of these data and how FDA interprets them in the approval decision process.
authors.affiliation: Center for Devices & Radiological Health Food & Drug Administration Rockville, Maryland.
authors.forename: D M
authors.initials: DM
authors.lastname: Johnson
authors.forename: D J
authors.initials: DJ
authors.lastname: Chwirut
authors.forename: W F
authors.initials: WF
authors.lastname: Regnault
mesh_terms: D001696:Biomechanical Phenomena; D006350:Heart Valve Prosthesis / Q000592:standards*; D006801:Humans; D008422:Materials Testing / Q000592:standards; D011474:Prosthesis Design / Q000592:standards; D011475:Prosthesis Failure; D014481:United States; D014486:United States Food and Drug Administration