FDA宣布批准医疗设备的“独特”限制
食品和药物管理局在批准的医疗设备的销售和分销上宣布了另一种“独特的限制”。FDA发布了一个需要医疗提供者和设施的订单，提供本发明永久避孕设备，为患者提供关于设备的风险和益处的特定信息。这不是第一个......
ISO 18562 VOC and Particle Testing for Medical Devices
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The regulatory approval process for medical devices is complex and not always well defined. The Food and Drug Administration (FDA) is the federal agency responsible for the regulatory oversight of medical devices in the U.S. Most medical device premarket reviews conducted …
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Trump directs USTR to take up pricing of pharmaceuticals, medical devices
Donald Trumper Goday总裁指导了他的顶级贸易谈判代表，强烈承担所有国家，修复美国药品和医疗设备的价格。特朗普表示，在美国的研发时，其他国家的价格下，其他国家的价格如不合理和完成，我们可以更长时间容忍这种行为......
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2018年行业监管教育（REDI）春季会议
The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA), and Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE) are pleased to announce a co-sponsored event developed just for you the Regulatory Education for Industry conference. The Regulatory Education for Industry (REdI) Conference is …
Final Guidances on Next Generation Sequencing | In Vitro Diagnostics
5月24日星期四，FDA将举办关于两个最终确定的指南的网络研讨会，该指导旨在加强研究人员之间的协作，并推动基于新的下一代测序（NGS）的测试的有效开发。下一代测序（NGS），大规模平行或深度测序是描述具有革命性的基因组研究的DNA测序技术的相关术语。DNA测序是......
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Regulation Of Imaging Equipment Strengthen By Government
The government has decided to tighten the reins on ultrasound machines and similar imaging equipment in order to prevent companies from importing these products into India without proper registration. The move is also expected to ensure that these products follow high-quality standards and are easier for the government to track in order to prevent abuse …
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扩展CDSCO谁是GMP证书
In a move to improve ease of doing business, India is increasing the validity of the World Health Organisation(WHO) Good Manufacturing Practices (GMP) certificate to three years. The CDSCO WHO GMP certificate was earlier valid for two years, said Drug Controller General of India Eswara Reddy during the 6th annual International Exhibition of Pharma and Healthcare (iPHEX) on Tuesday. The measure would also …
FDA Releases Draft Guidance for Multiple Function Devices
FDA has issued a draft guidance for Multiple Function Devices to clear up its policy for products that have more than one function. The draft, Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration Staff, is related to Digital Health and the 21st Century Cures Act. It suggests that …
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Opportunity for Device Manufacturers on De Novo Pathway Extension
当FDA添加De Novo Pathway 1997年作为医疗器械制造商寻求I II类或II类分类的替代途径。即使医疗设备产品自动归类为III类设备。FDA的初始De Novo进程保留了公司首先提交的申请要求......
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Medical Device Accessories Guidance | Food Drug and Cosmetic Act
The FDA issued Medical Device Accessories –Guidance for Industry and Food and Drug Administration Staff, which applies to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) for combination products. The #guidance document offers welcomed clarity on the role of an “accessory” and its regulatory relationship to its parent device. As always, guidance documents are …
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