一、Test(s) performed You should identify the tests performed. If the testing was conducted as recommended by a FDA guidance document or FDA-recognized consensus standard. we recommend that you state such in the test report summary. 说明已执行的测试是否是按照FDA指导文件或FDA认可的共识标准进行检测...
RecognizedConsensusStandards:MedicalDevices 1to500of1496Results123ResultsperPage500 NewSearchExportToExcelStandardsSearchAssistance DateofRecognitionExtentof EntrySpecialtyTask8NumberRecognitionStandards 6GroupArea1012DevelopingStandardDesignationTitleofStandard 9NumberandDate ...
一、Test(s) performed You should identify the tests performed. lf the testing wasconducted as recommended by a FDA quidance document or FDA-recognized consensus standard. we recommend that you state suchin the test report summary. 说明已执行的测试是否是按照FDA指导文件或FDA认可的共识标准进行检测。
Being a curious person, I wanted to see what FDA has done with that authority by looking at the CDRH database forRecognized Consensus Standards: Medical Devices. My main takeaway is that CDRH is not yet investing enough time and energy in recognizing standards that support digital he...
(e.g., the half-cycle method) but not the validation data itself. The submission should also identify all relevant consensus standards used and identify any aspects of the standards that were not met. In the absence ...
How FDA-Recognized Standards Impact Users, ManufacturersMany consensus standards have been developed to address aspects of medical device safety and/or performance. A consensus standard is a voluntary standard developed by a national or international standards development organization, typically by a group...
一、Test(s)performedYoushouldidentifythetestsperformed.lfthetestingwasconductedasrecommendedbyaFDAquidancedocumentorFDA-recognizedconsensusstandard.werecommendthatyoustatesuchinthetestreportsummary.说明已执行的测试是否是按照FDA指导文件或FDA认可的共识标准进行检测。 二、Objective(s)ofthetest(s)Youshouldprovidetest...
值得让人注意的是,通常二类器械不光产品要满足“一般控制”(General Control)的要求,提交审批注册申请只要,还需要满足“特殊控制”(Special Control)的要求,例如说 某些器械有国际标准,FDA认可的协调标准(FDA recognized consensus standard), 完整的质量系统等等。
27 28 For the current edition of the FDA-recognized standard(s) referenced in this document, see the 29 FDA Recognized Consensus Standards Database.2 For more information regarding use of 30 consensus standards in regulatory submissions, please refer to the FDA guidance titled 31 “Appropriate ...
(s) referenced in this document, see the FDA Recognized Consensus Standards Database. The information in this guidance is intended to be used in conjunction with other FDA guidance documents, including device-specific guidances such as Infusion Pum...