美国当地时间2024年2月20日, FDA发布了一则关于“上市前提交的实验室检测数据中存在欺诈和不可靠:美国食品药品监督管理局提醒医疗器械制造商审查第三方实验室生成的数据”的公告。 https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-f...
原文链接: https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device ASCA实验室网址: https://www.fda.gov/medical-devices/division-standards-and-conformity-assessment/asca-accredited-testing-laboratories 美国...
原文网址:Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions: FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated Data | FDA 美国食品和药物管理局(FDA) 发布提示:提醒器械研究的申办者和器械制造商(“器械公司”)仔细评估他们聘请的进行性能测试的第三方,并在提交给...
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm446729.pdf. [3]O’BRIENP.A multiple testing procedure for clinical trials[J].Biometrics,1979,35(3) : 549-556. [4]POCOCK S J . Group sequential methods in the design and analysis of clinical trials[...
NMPA Medical Device Registration In recent years, the medical device industry has developed rapidly in China, and more and more enterprises are paying attention to this field. However, to sell and operate medical devices legally in China, it is necessary to go through the NMPA medical device reg...
NMPA Medical Device Registration In recent years, the medical device industry has developed rapidly in China, and more and more enterprises are paying attention to this field. However, to sell and operate medical devices legally in China, it is necessary to go through the NMPA medical device reg...
http://med.anytesting.com 以下为正文: 在医疗器械准备美国FDA的上市前申请时,比如510K、PMA、De Novo创新申请,涉及到需要提交相关的测试报告,而这些测试报告中,生物相容性报告以其发补多、花费高、时间长等特点成为企业关注的焦点和头等准备大事。 以下从企业关心和FDA...
2. Test for OSCS in crude heparin in each lot of every shipment before use in the manufacture or preparation of a drug (including APIs, drug products, and heparin components for use in a medical device). The test method should be qualified for use in testing crude heparin and suitable ...
Eurofins Medical Device Testing TÜV SÜD America NSF Health Sciences 这只是一些提供FDA注册代理服务的机构的例子,市场上还有其他公司提供类似的服务。 在选择代理机构之前,您可以通过调查他们的专业背景、经验、客户评价和服务范围来评估他们的可靠性和适合性。同时,建议与多家机构联系,了解他们的服务细节、收费结...
2021年5月20日 FDA Center for Devices and Radiological Health正式发布了“磁共振(MR)环境中医疗器械的安全检测和标记指南(Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment)”,该指南草案在2019年8月已发布,正式稿取代了 2014年发布的“Establishing Safety and Compatib...