U.S. Regulatory Considerations for Heart Valves Implanted by Minimally Invasive Surgery

Cardiovascular Engineering and Technology

Volumn 2, Issue 2, 2011, Pages 62-65

  Aguel, Fernando ^a   Hillebrenner, Matthew ^a   Stewart, Sandy F C ^a   Swain, Julie ^a   Hampshire, Victoria ^a   Zuckerman, Bram ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

Percutaneous heart valves; Regulatory; Standards

Indexed keywords

CLINICAL TRIAL; DYNAMIC ENVIRONMENTS; FOOD AND DRUG ADMINISTRATION; GUIDANCE DOCUMENT; HEART VALVES; IMPLANTATION SITES; IN-VITRO; IN-VIVO; ISO STANDARDS; MEDICAL DEVICES; MINIMALLY INVASIVE SURGERY; NEW MATERIAL; OPEN-HEART SURGERY; PROSTHETIC HEART VALVE; RANDOMIZED CONTROLLED TRIAL; REGULATORY; REGULATORY CONSIDERATIONS; TESTING REQUIREMENTS;

BIOMEDICAL ENGINEERING; EXPERIMENTS; MATERIALS TESTING; SAFETY VALVES; SURGERY;

HEART;

ARTICLE; CLINICAL EVALUATION; CLINICAL TRIAL (TOPIC); DEVICE SAFETY; GOVERNMENT REGULATION; HEART VALVE PROSTHESIS; HEART VALVE REPLACEMENT; HUMAN; IN VITRO STUDY; IN VIVO STUDY; MINIMALLY INVASIVE SURGERY; NONHUMAN; PRACTICE GUIDELINE; UNITED STATES;

EID: 79955843141     PISSN: 1869408X     EISSN: 18694098     Source Type: Journal    
DOI: 10.1007/s13239-010-0031-5     Document Type: Article

References (10)

1. Biological evaluation of medical devices Part 2: Animal welfare requirements ISO 10993-2: 2006.
2. Cardiovascular implants-Cardiac valve prostheses. ANSI/AAMI/ISO 5840: 2005.
3. Draft Guidance for Industry and FDA Staff: Heart Valves-Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications, Submitted for Comment, January 20, 2010, http://www. fda. gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM198043. pdf.
4. Draft International Standard ISO 5840-3, Cardiovascular implants-Cardiac valve prostheses-Part 3: Heart valve substitutes implanted by minimally invasive techniques.
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6. Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices, http://www. fda. gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM220772. pdf.
7. http://www. fda. gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077274. htm.
8. S. N. Rosenbloom and R. Corbett. An Assessment of ASTM F 2129 Electrochemical Testing of Small Medical Implants-Lessons Learned. Paper no. 07674, NACE 2007, Houston TX, 2007.
9. Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices, ASTM F2129.
10. 21 CFR Part 58, Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies.