Posted 30 October 2015
By Zachary Brennan
At the second meeting focused on the fourth iteration of the Medical Device User Fee Agreements (MDUFA) for 2017, both the US Food and Drug Administration (FDA) and industry reiterated agreement that the program overall has improved and is heading in a positive direction.
The negotiations center on the use of a system whereby medical device companies pay fees to FDA to register their establishments and list their devices with the agency. The fees help FDA increase the efficiency of the regulatory processes, with a goal of reducing the time it takes to bring safe and effective devices to market.
In early October, staffers from FDA's Center for Devices and Radiological Health (CDRH) met with industry representatives, including those from industry groups AdvaMed, the Medical Imaging and Technology Alliance (MITA), the American Clinical Laboratory Association (ACLA) and the Medical Device Manufacturers Association (MDMA).
The two sides discussed FDA’s response to an industry-requested analysis of pre-submissions for investigational device exemptions (IDEs), reviewed CDRH information systems for premarket reviews and discussed the implementation of recommendations from Booz Allen Hamilton’s MDUFA II/III Evaluation and additional financial analysis.
Pre-Submissions for IDEs
In its explaining of the results of an analysis of pre-submissions for IDEs, based on an audit sample from FY 2013 and part of FY 2014, FDA said it determined that IDEs with pre-submissions have a greater likelihood of first cycle approval.
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a premarket approval application, while a small percentage of 510(k)s require clinical data to support the application.
"Although the available data support the conclusion that IDEs with pre-submissions have a greater likelihood of approval, the significance of this conclusion is complicated by the fact that data show it can take longer for an IDE study to be approved when it was preceded by a pre-submission," FDA said.
FDA noted the increased time is often due to pre-submissions being associated with more challenging IDE studies.
Another key finding by FDA was that Q-submission and de novo workload has been increasing. Q-submissions refer to the documents submitted by sponsors requesting feedback from FDA prior to an IDE meeting. And the de novo classification option is an alternate pathway to classify novel devices of low to moderate risk that were automatically placed in Class III after receiving a “not substantially equivalent” determination in response to a 510(k) submission.
FDA also described the trend of increasing numbers of pre-submissions and submission issue meetings (SIMs), and despite an increase in submissions for which there is no fee, FDA said it has continued to meet its performance goals.
The agency also said reviewers are providing feedback prior to pre-submission meetings more frequently in FY 2015 than prior years, which industry was appreciative of.
As far as guidance, industry also praised FDA’s effort to provide greater clarity via revisions of guidance documents, even though they "can inject more uncertainty since many are associated with new initiatives that require FDA staff and industry time to address." The ACLA, for instance, expressed concerns about the use of guidance in lieu of formal comment and rulemaking for substantial policy changes.
Also at the meeting, FDA presented a summary of CDRH’s implementation of a plan to address the recommendations in Booz Allen Hamilton’s MDUFA II/III Evaluation, which includes 11 recommendations for FDA to improve the efficiency and review times of the device submission review process.
The five categories of recommendations are Quality Management, Evaluation of Review Process, Evaluation of IT Infrastructure and Workload Tools, Evaluation of Training Programs, and Assessment of Staff Turnover.
CDRH said it completed preliminary work for seven of the 11 recommendations, including all four projects under the quality management recommendation. Other preliminary actions will be met by December 2015, FDA projected.
FDA noted that there was a decrease in the Budget Authority (BA) appropriations for medical devices in FY 2013 due to sequestration, and the agency has met the appropriation trigger related to the Devices and Radiological Health line of the budget each year of MDUFA III thus far.
FDA agreed to provide additional information on the 510(k) and de novo program to industry at the next meeting on 18 November.