Special 510(k)s: CDRH’s Proposed Program Expansion Draws Mixed Reactions

Regulatory NewsRegulatory News | 03 December 2018 |  By 

Industry cautioned the special 510(k) program expansion proposal could yield the opposite of its intended goal and further limit eligibility of changes that undergo special 510(k) reviews.

The main concern among several device companies, including Thermo Fisher Scientific, Cook Group and Fresenius Kabi USA, relates to a lack of clarity around the process used by agency staff to determine whether a submitted special 510(k) will be converted to a traditional 510(k) prior to being reviewed.

The concerns were raised in comments, posted Friday, on the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health’s new special 510(k) draft guidance. The center released the draft guidance in September to lay out changes to the special 510(k) program. All special 510(k)s submitted to CDRH after 1 October have been evaluated under a pilot the center subsequently launched to operationalize the proposed expansion.

An overarching policy modification in how change eligibility is determined for the purposes of a special 510(k) involves focusing on whether the method to evaluate a change is well-established and data can be reviewed in summary formats. The new draft guidance also includes industry-supported policy changes such as covering indications for use and providing a justification for converting special 510(k)s.

The commenters supported CDRH’s move to update the 1998 policies as the special 510(k) approach can provide time and cost savings compared to traditional 510(k) submissions. But they argued that CDRH’s expansion framework, as currently drafted, may hinder greater program participation. They cited a lack of consistency, clarity and transparency around the drafted framework and CDRH internal processes.


“In a few areas, the proposed text may cause unintended consequences and unnecessarily restrict changes in certain device types from being reviewed through a special 510(k), even though there are well-established methods with clearly defined endpoints available to verify that the modified device will be substantially equivalent to the previously cleared device,” said Ruey Dempsey, VP of technology and regulatory affairs at AdvaMed. The industry trade association was among the commenters that recommended several changes to CDRH’s proposed draft framework and additional policy clarifications.

Another concern among most commenters relates to identifying in-scope device changes to aid industry and CDRH in determining whether special 510(k) reviews are appropriate. The argument for clearly identifying eligible device types and changes specifically involves a potential decrease in the number of special 510(k) submissions converted to traditional 510(k)s by providing greater clarity to applicants.

How several common device changes will be considered under the expanded framework remains unclear, according to commenters. These include the addition of new indications for use, deviations to manufacturing protocols and material changes that require biocompatibility data. The scope of software- and cyber-related modifications remains unclear as well, according to AdvaMed and Deloitte.


Other concerns relate to the use of animal data, complete test reports and revised voluntary consensus standards that previously received FDA recognition. The commenters, however, also offered recommendations to aid the agency in achieving the intended purpose of the expanded program.

Fresenius and Cook called on CDRH to address its abbreviated 510(k) program in the special 510(k) draft guidance. They pointed to draft guidance CDRH issued earlier this year to propose an expansion of its abbreviated 510(k) program. This draft guidance also raised questions among industry groups with regard to the intended benefit of providing greater flexibility to manufacturers seeking 510(k) clearance.

In addition, the commenters suggested implementing new policies and procedures under the expanded special 510(k) program to deliver on transparency. These include a new process that can be used by an applicant if a CDRH rationale for special 510(k) conversion is “questionable,” a “defined mechanism” to obtain feedback from CDRH and an “option to have an early consultation meeting" with agency staff.

Measures of Success

Meanwhile, CDRH officials offered some additional details around the ongoing special 510(k) pilot during an FDA workshop last month. They outlined the measures that will dictate the pilot’s success.

Pilot success will be based on total number of special 510(k)s received and the total number of special 510(k)s converted to traditional 510(k)s. The pilot will also track the day a special 510(k) was placed on hold, the reason for the decision and the day on which it was made, as well as total time to decision.

The pilot will serve CDRH in determining whether the proposed device eligibility expansion can help achieve the efficiencies sought in preparing 510(k) submissions and conducting 510(k) reviews. It will run until there is sufficient information to evaluate its success, according to CDRH’s Angela DeMarco.

The efforts around special 510(k)s, abbreviated 510(ks) and now traditional 510(k)s speak to the measure of success CDRH set in its three-year roadmap earlier this year to have upwards of 50% of novel technology manufacturers come to the US first or in parallel with other markets. This was reinforced with a new goal on global impact added via recent updates to FDA’s medical device safety action plan.



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