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。
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。
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。
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。
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 The draft guidance proposed to expand the Abbreviated 510(k) program at FDA’s Center for Devices and Radiological Health (CDRH), with the agency arguing for more modern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.