單價: | 面議 |
發貨期限: | 自買家付款之日起 天內發貨 |
所在地: | 廣東 深圳 |
有效期至: | 長期有效 |
發布時間: | 2023-12-14 15:38 |
最后更新: | 2023-12-14 15:38 |
瀏覽次數: | 112 |
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以下幾種情況下需要做FDA510(K) 變更
A change in indications for use from prescription use to over the counter use
Addition of a new patient population
Changes to the environment of use such as from professional use to home use or hospital use to ambulatory transport
Changes in frequency or duration of use
Change to indicate compatibility with a type of device, component, or accessory that was not indicated as compatible with the previously cleared device
Changes in sterilization, cleaning or disinfection
Changes in package integrity or shelf-life claims
Changes in device design
Changes to employ wireless communication
Changes in the human factors of the patient or user interface
A change in material type, formulation or chemical composition
Changes in the antibody, detection reagents, critical reaction components or conjugates for in vitro diagnostic (IVD) devices
更多美國FDA醫療器械產品注冊備案常見問題及方案解決請聯系深圳市思博達彭先生或登錄公司網站www.bccgd.com。
深圳市思博達管理咨詢有限公司是一家從事醫療器械國際咨詢的專業性咨詢機構。提供各個國家或地區醫療器械注冊認證,包括中國NMPA、美國FDA、510(K)、歐盟MDR CE認證、加拿大MDL認證、澳洲TGA認證等等、醫療器械質量體系審查,如中國醫療器械GMP(包括試劑類)、美國QSR820質量體系場考核、歐盟GMP、日本GMP、巴西GMP、ISO13485等)等多種國際注冊及認證的咨詢、代理服務;也可為您提供醫療器械風險管理、軟件確認、滅菌確認、臨床評估、可用性確認等專題培訓服務。