20160121 ECA新闻：FDA公布2016年医疗器械计划发布的指南清单

20160121 ECA新闻：FDA公布2016年医疗器械计划发布的指南清单  

GMP News
21/01/2016

FDA publishes List of Planned Guidances on Medical Devices for 2016

FDA公布2016年医疗器械计划发布的指南清单

At the end of 2015, the Center for Devices and Radiological Health (CDRH) published a list containing the guidelines planned for fiscal year 2016 (1st October 2015 - 30 September 2016) as well as older guidelines which might need an update.

在2015年末，CDRH公布了一个2016年计划公布的指南清单（2015年10月1日至2016年9月30日），以及可能需要更新的旧的指南清单。

The CDRH is FDA's department in charge of regulating medical devices. CDRH's guidelines, policies, etc. are the basis for FDA's inspections of medical device manufacturers too. The actual list is just as long as a paper page.

CDRH是FDA负责医疗器械法规的部门。CDRH的指南、政策等也是FDA进行对医疗器械生产商进行检查的基础。实际的清单其实只有一页纸。

Interestingly, the CDRH has divided its list in priority A and B. The documents in the A-list should be published at first. Provided that sufficient resources are available after the A priorities have been processed, those documents are also intended to be published in 2016. Beneath this, the FDA has included - relatively pragmatically - the finalisation of current draft documents.

有意思的是，CDRH将清单分为A级优先和B级优先。在A级清单里的文件要优先公布。如果在A级内容处理完后还有足够的资源，则B级里的文件也会在2016年公布。此外，FDA还包括了，相对比较务实，现行草案文件的定稿。

The list of guidelines which are subject to a retrospective review in 2016 comprises 4 pages and is significantly longer. They include guidelines from 1976, 1986, 1996 and 2006. Next year, the guidelines from 1977, 1987, 1997 and 2007 will be reviewed, etc. This 10-year review cycle should continue until  2025. Interested persons are explicitly invited to comment on those lists.  

用于2016年回顾的指南清单有4页之长，是够长的了。其中包括了1976年、1986年、1996年和2006年的指南。下一年度，1977年、1987年、1997年和2007年度的指南要进行审核。此十年审核周期应持续直到2025年。FDA邀请感兴趣的人们对这些清单提出建议。

It is interesting to notice that the document deals with the question whether the CDRH expects from the list planned to be also fully implemented. The answer is "no" even if the word "no" doesn't appear as such in the text. There may be setbacks due for example to the creation of new guidelines with regard to emerging issues - or due to new priorities of the employees which couldn't be foreseen (e.g. concerning authorisation or vigilance activities).

有意思的是，CDRH是否期望计划清单真的都能实施呢？回答是“不”，即使在文件中并没有说“不”这个词。可能会有一些事情拖累导致延迟，例如，关于新问题创建新的指南，或者由于无法预见的人员优先问题（例如，授权或警戒活动）。

That is the reason why interested groups are expressly invited to communicate to the FDA their prioritisation with regard to essential guidelines in the diverse areas in order to enable the FDA to make a customer-oriented use of its resources when planning the creation of new guidelines or revising old guidelines.

这是为什么广泛邀请利益相关组织来与FDA沟通其在大范围领域里基础指南的优先问题，这样能让FDA根据客户要需求来配置其资源，根据需要创建新的指南或修订旧的指南。

Conclusion: With the publication of the list of guidelines planned for medical devices in fiscal year 2016, the FDA has submitted a declaration of intent. Guidelines directly addressed to the quality assurance system or "GMP" are not explicitly including in the A-/B-list.

结论：通过公布其2016财年医疗器械计划指南清单，FDA表明了其意图。在A/B清单中，并没有清楚直接与质量保证体系或“GMP”相关的指南。

All details can be found in the complete list: "CDRH Fiscal Year 2016 (FY 2016) Proposed Guidance Development and Focused Retrospective Review of Final Guidance.

详细信息参见完整清单。

A清单Prioritized medical device guidance documents that the Agency intends to publish in FY 2016 ("A-list")Final Guidance Topics定稿指南主题

General Wellness Products	通用健康产品
Medical Device Accessories	医疗器械辅助物
Benefit-Risk Factors to Consider when Reviewing IDE Submissions	审核IDE申报时要考虑的利益-风险因子
UDI Direct Marking	UID直接标示
Adaptive Design for Medical Device Clinical Studies	医疗器械临床研究适应性设计
Incorporating Patient Preferences into Medical Devices Premarket Approvals, Humanitarian Device Exemptions, and De Novo Classifications	患者偏好结合至医疗器械的上市前批准，慈善装置豁免和从头测序分类
Applying Human Factors & Usability Engineering to Optimize Medical Device Design	应用人类因子&可用工程来优化医疗器械设计
Policy for Regulatory Oversight of Laboratory Developed Tests (LDTs)	实验室研发测试（LDTs）法规监管方针
Submission and Review of Sterility Information for Devices Labeled as Sterile	标识为无菌器械的无菌资料的提交和审核
Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing (Biocompatibility)	使用ISO 10993-1，医疗器械生物评估第I部分：评估和测试（生物相容性）
Postmarket Surveillance Studies Under Section 522 of the Food, Drug, and Cosmetic Act	根据食品药品和化妆品法案522部分的上市后监管研究
Medical Device Reporting (MDR) for Manufacturers	生产商医疗器械报告（MDR）

Draft Guidance Topics指南草案主题

Medical Device Decision Support Software	医疗器械决策支持软件
Use of Symbols in Labeling	标签符号的使用
510(k) Modifications	510（K）修正
Software Modifications	软件修订
510(k) Third Party Review Program	510（K）第三方审核程序
Companion Diagnostics Co-Development	可对话共同开发指南
Use of Real-World Observational Patient Data to Support Decision Making for Medical Devices	使用真实观察的患者数据来支持医疗器械决策
UDI Convenience Kit	UDI便利盒
Public Notification of Emerging Postmarket Medical Device Signals	新上市后医疗器械信号的公众通知

B清单
Device guidance documents that the Agency intends to publish, as the Agency’s guidance-development resources permit each in FY 2016 ("B-list")Final Guidance Topics定稿指南主题

Reporting of Computational Modeling Studies in Medical Device Submissions	医疗器械申报中计算模型研究报告
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use	使用点处方用血液葡萄糖监测系统
Self-Monitoring Blood Glucose Meters for Over-the-Counter Use	OTC用自我监测血液中葡萄糖计
Radiation Biodosimetry Devices	放射性生物计量测试装置
Finalizing existing draft guidance documents.	将已有指南草案文件定稿

Draft Guidance Topics指南草案主题

Medical Device Interoperability	医疗器械协作性
Patient Access to Information	患者获取信息通道
Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies	医疗器械临床研究中年龄、种族和血统数据的评估和报告
Patient Matched Instrumentation for Orthopedics	整形外科患者适配器械
Dual 510(k) and Clinical Laboratory Improvement Amendments Act (CLIA) Waiver by Application	双重510（K）和临床实验室
Defining the Unique Device Identifier (UDI)	唯一器械识别号（UDI）定义
Critical to Quality Information for Abdominal Surgical Mesh Devices	腹部外科手术网装置关键质量信息
Critical to Quality Information for Hydrophilic Coated and Hydrophobic Coated Vascular and Neurological Devices	亲水和疏水涂布血管和神经装置关键质量信息

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