Draft Guidance for Industry and FDA Staff: Heart Valves

Embed Size (px)

Text of Draft Guidance for Industry and FDA Staff: Heart Valves

  • 1. Draft Guidance for Industry and FDAStaffHeart Valves - Investigational Device Exemption (IDE) and PremarketApproval (PMA) Applications DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: January 20, 2010Comments and suggestions regarding this draft document should be submitted within 90 days ofpublication in the Federal Register of the notice announcing the availability of the draftguidance. Submit written comments to the Division of Dockets Management (HFA-305), Foodand Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Alternatively,electronic comments may be submitted to http://www.regulations.gov. Allcomments should be identified with the docket number listed in the notice of availability thatpublishes in the Federal Register.For questions regarding this document contact Carolyn D. Vaughan, Office of Device Evaluation,301-796-6338, or Sandy F.C. Stewart, Office of Science and Engineering Laboratories, 301-796-2518.U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Circulatory Support and Prosthetic Devices BranchDivision of Cardiovascular DevicesOffice of Device Evaluation

2. Contains Nonbinding RecommendationsDraft - Not for Implementation PrefaceAdditional CopiesAdditional copies are available from the Internet at:http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/umc193096.htm. You may also send an e-mail request to dsmica@fda.hhs.gov to receive anelectronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy.Please use the document number (1607) to identify the guidance you are requesting. 3. Contains Nonbinding RecommendationsDraft - Not for ImplementationTable of ContentsI.INTRODUCTION.........................................................................................................................................1II. BACKGROUND............................................................................................................................................2III.SCOPE ...........................................................................................................................................................2IV. RISK ANALYSIS..........................................................................................................................................3V.THE PRE-SUBMISSION PROCESS..........................................................................................................4VI. IDE AND PMA APPLICATIONS: GENERAL CONSIDERATIONS...................................................4VII.TERMS AND DEFINITIONS......................................................................................................................5VIII. DEVICE DESCRIPTION.............................................................................................................................5DEVICE PARAMETERS ................................................................................................................................................5PACKAGING INFORMATION ........................................................................................................................................7IX. PYROGENICITY .........................................................................................................................................8X.STERILIZATION.........................................................................................................................................8XI. PRECLINICAL IN VITRO ASSESSMENT .............................................................................................10A.VALVE SAMPLES ............................................................................................................................................11B.REFERENCE VALVES ......................................................................................................................................11C.BIOCOMPATIBILITY ........................................................................................................................................11D.VALVE DURABILITY TESTING ........................................................................................................................12E.COMPONENT FATIGUE TESTING .....................................................................................................................12F.DYNAMIC FAILURE MODE TESTING ...............................................................................................................12G.CAVITATION...................................................................................................................................................12H.CORROSION RESISTANCE ...............................................................................................................................13I.FLAMMABILITY OF VALVED CONDUITS .........................................................................................................13J.HEMODYNAMIC PERFORMANCE - VERIFICATION OF THE BERNOULLI RELATIONSHIP ....................................13K.MAGNETIC RESONANCE (MR) SAFETY TESTING ...........................................................................................13L.SHELF LIFE.....................................................................................................................................................14XII.PRECLINICAL ANIMAL STUDIES .......................................................................................................14A.METHODS .......................................................................................................................................................14B.STUDY DESIGN ...............................................................................................................................................14C.DATA COLLECTION ........................................................................................................................................15D.DATA ANALYSIS ............................................................................................................................................16E.FINAL REPORT OF ANIMAL STUDY .................................................................................................................16F.SUBMITTING ANIMAL STUDY INFORMATION TO YOUR IDE AND PMA ..........................................................17XIII. CLINICAL INVESTIGATIONS ...............................................................................................................18A.DATA SAFETY MONITORING BOARD ..............................................................................................................18B.CLINICAL EVENTS COMMITTEE ......................................................................................................................18C.NUMBER OF INVESTIGATORS..........................................................................................................................18D.INVESTIGATIONAL SITES ................................................................................................................................19E.DATA COLLECTION ........................................................................................................................................19F.CONTROL DATA .............................................................................................................................................19G.SAMPLE SIZE AND FOLLOW-UP EFFECT ON COMPLICATION RATE .................................................................20H.PRE-OPERATIVE DATA ...................................................................................................................................21I.FOLLOW-UP DATA .........................................................................................................................................22J.CLINICAL LABORATORY RESULTS IN CHILDREN ............................................................................................23 4. Contains Nonbinding Recommendations Draft - Not for Implementation K.IMAGING DATA ..............................................................................................................................................23 L.ADDITIONAL INFORMATION ...........................................................................................................................23 M.DATABASE CLOSURE .....................................................................................................................................24 N.SUBJECT COMPLIANCE ...................................................................................................................................24 O.DATA POOLING ..............................................................................................................................................25 P.ADVERSE EVENTS AND COMPLICATION RATES..............................................................................................25 Q.FOREIGN DATA ..............................................................................................................................................25XIV. PMA SUPPLEMENTS ...............................................................................................................................25 A.MODIFICATIONS TO THE SEWING RING CONFIGURATION ...............................................................................26 B.VALVED CONDUITS ........................................................................................................................................26XV.PROFESSIONAL LABELING..................................................................................................................26 A.NON-STERILE DEVICES ...........................................................