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FDA的Patel如是说:是时候改变软件的评审模式了

阅读: 2016年09月30日


     美国FDA医疗器械与放射健康中心(CDRH) 负责数字健康的副主任就FDA如何规范高风险医疗软件的问题进行了探讨。



认识到软件开发的进程如此之快,FDA正在寻找规范高风险医疗软件产品的最佳途径。监督最棘手的部分在于尝试确保安全的同时保持创新的快速发展。


“我们能不能重新审视一下这个模式,想一想,评审和监督软件的最好方式是什么?因为这不是物理实体。它的变化很快。它的迭代速度比物理世界中我们所知的其他任何产品都要快,” FDA负责数字健康的副主任Bakul Patel在上周(6月13-15日)纽约市举办的美国东部医疗器械展览会(MD&M East)的会议上如此说道。


Patel呼吁参会人员告诉FDA,作为软件开发者,质量体系法规是如何为他们工作的。许多开发者使用的是一套以快速周转、不断完善和快速适应性为特征的敏捷软件开发方法。当然,这种连续的变化意味着监管更具挑战性。 “其中的一个问题在于软件开发的离散步骤比实体器械少,”Patel表示。


尽管这一周简短的讨论并没有取得任何令人满意的结论,但作为国际医疗器械监管机构论坛(IMDRF)工作组(作为医疗器械的软件(SaMD))的主席,Patel还是解答了其中的某些问题。SaMD与医疗器械中的软件不同。SaMD工作组于2014年发布了一个框架,根据医疗状况或条件的严重程度以及所提供的信息预期对医疗决策的影响水平将软件分成了四大类。那些旨在治疗或诊断关键医疗条件的软件将归为影响最高的类别-IV类。根据该框架文件,一个作为医疗器械的IV类软件的例子是用于急性脑卒中治疗决策的诊断图像分析。影响最低的I类软件包括测量以及向医生发送诸如心脏康复患者的心率、距离和行走速度等指标的SaMD软件。一份发布于2015年的IMDRF文件对SaMD的质量管理体系的要素进行了讨论,其中包括与用户、器械、用途、安全性和使用环境相关的风险。


FDA在过去已经着手处理医疗APP的监管问题,采取了低干涉的方式缩小其监督范围。Patel指出,给患者带来益处同时又不危及患者安全的大多数产品,比如简单的通讯工具、健康信息的追踪或者使医生一部分工作自动化的功能,都是FDA施行执法自由裁量权且不实施监管的产品。


尽管如此,有些方面还是令人困惑的。上周会议的谈论环节包括用于确定风险评分和测量值的数字计算器。许多这类计算器不受FDA的监管,因为这些计算器只是对医生的计算进行复核的工具。不过,计算胰岛素剂量的数字计算器由于其由患者在家(而不是医生)用于治疗决策而被纳入FDA的监管范围之内。


Morgan Reed是代表着超过5000个APP制造商和软件公司的竞争性技术协会(ACT)下的App协会(The App Association)的主席,他在会议结束时鼓励参会人员给FDA和App协会提交可能对其制定方法有帮助的想法、文章和文件。这不可能是一个简易快捷的过程。“困难的是听到FDA说‘我不知道,你告诉我们吧’。尤其艰难的是,到了要面对你的投资商和业务部门的时候,你却告诉他们你得到的回复是‘我不知道’”,Reed说道。


英语原文


FDA's Patel: Time for a Paradigm Shift in Software Review



CDRH's associate director for digital health discusses the question of how FDA can best regulate higher-risk medical software.


Recognizing the fast pace of advancement in software development, FDA is searching for the best way to regulate higher-risk medical software products. The tricky part of oversight comes in trying ensure safety while maintaining a rapid pace of innovation.


"Can we re-look at the paradigm and see-what is the best way to review and have oversight of software? Because it's not physical. It changes fast. It iterates faster than any other product we know in the physical world," said Bakul Patel, associate director for digital health at FDA, during the MD&M East Conference this week in New York City.


Patel appealed to the audience members to tell FDA how the quality system regulations work for them as software developers. Many developers use agile software development, a methodology that is characterized by quick turnaround, constant improvement, and fast adaptability. Of course, this continuous change means regulation is even more challenging. "One of the problems is, there are less discrete steps in software development than exist in a physical device," Patel said.


While this week's brief discussion didn't yield any satisfactory conclusions, Patel has addressed some of these questions as chair of the International Medical Device Regulators Forum (IMDRF) working group on Software as a Medical Device (SaMD). SaMD is different from software in a medical device. In 2014, the SaMD working group released a framework that would classify software into one of four categories, based on the seriousness of the healthcare situation or condition and the level of impact the information provided is expected to have on a healthcare decision. Software that aims to treat or diagnose a critical healthcare condition would be in the highest impact category, Category IV. According to the framework document, an example of a Category IV SaMD would be diagnostic image analysis used to decide treatment for acute stroke. The lowest-impact category I would include a SaMD that measures and send metrics like heart rate, distance, and walking speed for a cardiac rehab patient to a clinician. An IMDRF document released in 2015 discusses quality management system considerations for SaMD, including risks related to users, the device, the application, security, and use environment.


In the past, FDA has tackled the question of regulating medical apps, taking a light touch that narrowed the scope of its oversight. As Patel pointed out, most products that offer a benefit without endangering the patient, such as simple communication tools, tracking health information, or features that automate parts of a clinician's job, are products for which FDA practices enforcement discretion and does not regulate.


Still, there can be some points of confusion. Discussion at the conference session this week included digital calculators used to determine risk scores or measurements. Many of these would not be regulated by FDA because they serve as tools to double-check the clinician’s calculation. Yet insulin dose digital calculators would be covered by FDA because these are used at home by patients, not clinicians, to make treatment decisions.


Morgan Reed, executive director of ACT-The App Association, which represents more than 5000 app makers and software companies, concluded the session by urging the audience members to send FDA and The App Association ideas, articles, documents that might help the agency develop its approach. It's not likely to be a quick or easy process. "It's hard when the FDA says to us, 'I don't know, you tell us.' That's a very hard thing when it comes to meeting with your investors and the rest of your business unit that you got an 'I don't know,'" said Reed.


来自:MassDevice

整理:奥咨达




(作者:佚名 来源:本站原创)
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