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Introduction to the US FDA Professional

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Original Title: Brief Introduction to the US FDA Guidelines on Key Points for Non-clinical Evaluation of Medical Devices Containing Nitinol Brief Introduction of FDA's Guideline on Nonclinical Evaluation of Medical Devices Containing Nitinol In October 2020, FDA of the United States issued the Guidelines for Non-clinical Evaluation of Medical Devices Containing Nitinol, which elaborated the key points of technical review of medical devices containing Nitinol. The contents of the Guidelines are briefly introduced as follows. I. Basic Concepts Nitinol is a near-equiatomic alloy of nickel and titanium, which has the properties of superelasticity and shape memory, and is widely used in cardiovascular devices such as heart stents, valves, guidewires, and other fields of medical devices. Compared with traditional metals such as stainless steel, titanium or cobalt-chromium alloys, nickel-titanium alloys have complex properties and are susceptible to many factors such as alloy composition, thermal processing, surface treatment, corrosion of biological tissues and so on. When evaluating its safety and effectiveness, it is necessary to focus on thermodynamic properties, process sensitivity and so on. II. Key points of technical evaluation (I) Basic information 1. Material composition If the material of the nickel-titanium alloy used in the device conforms to a recognized standard, it shall be specified in the application (e.g., ASTM F2063). If the material does not conform to a recognized standard,titanium bar gr5, the composition of the material shall be defined and its properties shall be described. 2. Manufacturing process The production process flow diagram shall be provided, especially the thermal process, surface treatment steps, final cleaning steps, etcoperty of nickel-titanium alloy. It is recommended to specify the phase transformation temperature of the finished product in the data. Refer to ASTM F2004 and ASTM F2082. (II) Mechanical test 1. Key points of experiment It is recommended to explain the control mode adopted for mechanical testing; for deformable implantable devices,nickel titanium wire, it is recommended to consider clinical deformation and temperature drift before mechanical testing; mechanical testing should be carried out at actual clinical temperature; if fatigue testing is carried out, it is recommended to use clinically relevant solvents (such as PBS); If the shape memory properties of the device are utilized, it is recommended that shape memory testing be performrefer to ISO 10993 -17. (V) Label information It is recommended that the label clearly indicate that the device contains nitinol, suggesting that it may cause allergic reactions in patients, nickel titanium wire ,Titanium 6Al4V wire, especially in long-term or permanent implanted devices. III. References: [1] FDA. Technical Considerations for Non-Clinical Assessment of MedicalDevices Containtration, US Medical Device GMP Certification Release date: 2021-07-06 20:07 Views: 27 In October 2020, FDA of the United States issued the Guidelines for Non-n It is recommended that the label clearly indicate that the device contains nitinol, suggesting that it may cause allergic reactions in patients,ti6al4v eli, especially in long-term or permanent implanted devices. III. References: [1] FDA. Technical Considerations for Non-Clinical Assessment of MedicalDevices Containing Nitinol - Guidance for Industry and Food and Drug Administration Staff. October 15, 2020 Tags: Medical Device FDA Registration, US Medical Device GMP Certification Return to Sohu to see more Responsible Editor:. yunchtitanium.com