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【奥译言】美国FDA大刀阔斧进行510k改革

2019-02-19 11:43 ?阅读数:3020 标签:

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美国食品药品监督管理局(FDA)的一项最终指南,为如何将510k许可的自主选择成为医疗器械监管审查的主要途径奠定了基础。


FDA于2018年4月发布的指南草案现已定稿,还换了一个新标题,同时这个新标题也是扩展替代方法的新名称,即“Safety and Performance Based Pathway”。该指南草案提议扩展FDA器械和放射健康中心(CDRH)的缩略510k计划,同时FDA主张在各个上市前环节中采用更为现代的器械性能测试方法。


推动FDA采用替代方法来证明医疗器械间的实质等同性,源于美国国会要求FDA对医疗器械采用“最不繁琐”方法。这也与FDA推动CDRH上市前通告(510k)途径现代化的做法相吻合。


FDA表示,最终指南“进一步扩展了缩略510k计划的概念,说明了如何以一种不那么繁琐但至少同样可靠的方式证明某些器械类型的实质等同性。采用这一扩展计划还可以提高对510k申请的审查效率,从而减少FDA的工作负担,还可能缩短对个别提交资料的审查时间。”然而,业内专家对指南文件中所描述的框架能否实现扩展计划的预期效益表示怀疑。


MC Morton Regulatory Consulting企业的首席顾问Michael Morton告诉Focus:“这是一项重大的政策措施,看来是FDA自己承担了一大堆工作。”这在一定程度上是因为FDA必须保留一份已公布的合格器械类型清单,并适时加以更新,使其符合共识标准,而这些标准会定期修订,以反映新信息。


此外,扩展计划的最终目标是将其作为510k许可的主要途径,而不是传统510k途径,而绝大多数通过传统510k途径的器械上市申请都由CDRH进行评估。


FDA于去年11月更新的《医疗器械安全性行动计划》中对此进行了描述。与此同时,FDA将会继续推动使用更现代的同品种医疗器械。


FDA局长Scott Gottlieb和CDRH主任Jeff Shuren周二表示:“大家认识到,某些成熟技术没有改进的必要,继续使用上市时间更早的同品种器械不仅适当,也很有必要。”他们提出了一份新的卷宗,旨在了解利益相关者对FDA针对传统510k所建议的新方法的反馈情况。这类计划还引起了许多业内专家对采用上市时间更早的同品种器械会带来哪些影响的关注。


业界提出的论点集中在,在当前框架下,可以更加灵活地选择传统510k、缩略510k或特殊510k申请,但却没有明确指出合格器械类型可能带来的潜在限制。


通过更多地使用替代方法,可以提高性能标准和自愿性共识标准的使用率。另一方面,提高扩展途径的使用率也依赖于FDA在为每种合格器械类型确定适当的性能标准的能力,同时FDA也需要与业界合作。然而,这些器械类型尚未确定,尽管去年发布草案后,FDA已承诺将会为此发布那些与上市时间超过10年的同品种器械作为等同器械上市的器械名单。在终版指南中可以看到FDA的这一承诺。


FDA在周二发布最终指南的同时,还建立了一个关于Safety and Performance Based Pathway的新网页。


“FDA打算在本网站上保留适用于Safety and Performance Based Pathway的器械类型清单,并附有确定了每种设备类型的性能标准的指南文件,本网站还包含多个适用指南中所建议的测试方法,以及任何其他相关信息,”FDA表示。


FDA对计划扩展政策的描述进行了稍微改动,旨在对先前的说法(“FDA认为,只有当FDA确定……新器械符合所有性能标准时,性能标准才适用”)进一步澄清(除此之外,还有其他两个限定条件)。


FDA在一份纳入指南的澄清声明中表示,“尽管FDA可能会推荐某种性能标准的测试方法,但申请者可能会选择采用不同于FDA所指定或推荐的测试方法来证明器械的性能特征”。


为反映该途径的新名称,还对指南草案进行了修订,在此之前称之为“缩略510k扩展计划”。然而,专家们认为,FDA在整个辩论中所用的语言文字错误地暗示,通过新途径进行审查和许可的器械与其他器械相比,前者的安全性和有效性更高。


英文原文


CDRH Revamps 510(k) Clearances With ‘Safety and Performance Based Pathway’


A US Food and Drug Administration (FDA) final guidance sets the stage for how the agency intends to make the voluntary option for 510(k) clearance the main pathway for medical device regulatory reviews.


The April 2018 draft version was finalized with a new title that is also the new name of the expanded alternative approach: “Safety and Performance Based Pathway.” The draft guidance proposed to expand the Abbreviated 510(k) program at FDA’s Center for Devices and Radiological Health (CDRH), with the agency arguing for more modern approaches to device performance testing in premarket settings.


The push for the alternative approach to demonstrating substantial equivalence stemmed from a Congressional ask for FDA to apply least burdensome provisions for medical devices. It also coincides with the agency’s push for modernization of CDRH’s premarket notification pathways.


The final guidance “expands the concept of the Abbreviated 510(k) program by explaining how substantial equivalence for certain device types may be demonstrated in a way that is less burdensome, but at least as robust,” FDA said. “Use of this expanded program may also make the review of 510(k) submissions more efficient, thereby reducing burdens on the agency and possibly review times for individual submissions.” Yet industry experts have expressed doubts as to whether the framework described in the guidance document will achieve the intended benefits of a program expansion.


This a “major policy” initiative, Michael Morton, principal consultant at MC Morton Regulatory Consulting, told Focus. “It seems to be FDA is taking on a whole bunch of work for themselves,” he argued. This is partly because FDA would have to maintain and update a published list of eligible device types to be consistent with consensus standards, which are routinely revised to reflect new information.


Further, the ultimate goal is for the expanded program to serve as the main pathway for 510(k) clearances as opposed to the traditional 510(k) pathway through which the vast majority of devices are evaluated by CDRH.


This was described in FDA’s Medical Device Safety Action Plan, which was updated last November. Meanwhile, the agency continues to push for use of more modern predicate devices.


“We recognize that for some types of well-established technologies there is not a need for improvements, and reliance on older predicates would not only be appropriate but necessary,” FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren said on Tuesday. They pointed to a new docket to obtain stakeholder feedback on the agency’s proposed approach to traditional 510(k)s. These plans have also raised concerns among industry experts over implications with older predicate devices.


The argument raised by industry centers on the current framework’s allowance for more flexibility in choosing either traditional, abbreviated or special 510(k) submissions without the potential limitations that could come from specifying eligible device types.


The increased use of an alternative approach can place greater emphasis on the use of performance criteria and voluntary consensus standards. Increased use of the expanded pathway is also banking on FDA’s ability—in collaboration with industry—to identify the appropriate performance criteria for each device type deemed eligible. Yet these device types have yet to be identified, despite committing to publishing a list for these purposes since last year’s draft. This commitment was retained in the finalized version.


The agency did set up a new webpage on the Safety and Performance Based Pathway in conjunction with issuing the final guidance on Tuesday.


“The FDA intends to maintain a list of device types appropriate for the Safety and Performance Base Pathway on this website, accompanied by the guidance documents that identify the performance criteria for each device type, as well as the testing methods recommended in the guidances where feasible, and any other relevant information,” FDA said.


The description of the policy for the program expansion was tweaked to further clarify that “FDA believes that use of performance criteria is only appropriate when FDA has determined that…the new device meets all the performance criteria” in addition to two other qualifiers.


“Although FDA may recommend test methodology for the performance criteria, a submitter may choose to use an appropriate testing methodology other than what is specified or recommended to demonstrate the performance characteristics,” FDA said in a clarification added to the guidance.


The draft guidance was also revised to reflect the new name of the pathway as this had been previously dubbed the “Expanded Abbreviated 510(k) program.” Experts have argued, however, that the language FDA has applied throughout the debate wrongly implies that devices that are reviewed and cleared via the new pathway are of higher safety and effectiveness compared to others.




内容来自:RAPS

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