The pace and process used by FDA for the review of combination products has been the subject of considerable concern by many device companies. On October 14, 2015, FDA’s Office of Planning issued a report summarizing a study of the intercenter consultation process for the agency’s review of combination products. The report identifies several challenges faced by FDA staff in reviewing combination products and makes recommendations for addressing the issues identified by the study.
As noted in the report, FDA initiated the study last year following concerns expressed by industry regarding the consistency and clarity of FDA’s communications related to combination product reviews, including in a 2014 industry survey. Consultations between agency centers during review of combination products are currently governed by internal procedures that were last updated in 2004.
The purpose of the study was twofold: (1) to “examine coordination within FDA for consulting across agency centers, including management, timing, timeliness, and workload challenges,” and (2) to “investigate interactions between applicants and FDA around combination product applications.” The study team conducted focus group discussions within CDRH and CDER and interviewed agency employees in leadership positions and key roles related to the review of combination products. The study team obtained input from industry representatives on issues faced by industry prior to developing the questions posed to focus group participants and interviewees.
The report identifies four issues frequently encountered by study participants:
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Different policies and practices between agency centers, making it “difficult for reviewers to develop a shared understanding of priorities and timelines during a review,” and differences in application types (and, therefore, review standards and data requirements), making it difficult to achieve consistency in review outcomes.
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An inability of centers to access other centers’ data systems in a timely manner and lack of a shared technical platform, which create delays and inefficiencies and result in communication gaps and reduced traceability of combination product submissions.
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A lack of clarity regarding cross-center communication channels, such that staff are not sure where to direct consult requests or how to follow-up on prior requests, and requests for consult that are incomplete or lack specificity, which result in response delays.
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A lack of additional funds to respond to the increasing demand for intercenter consults, “stretch[ing] already limited resources.”
In a FDA Voice post, FDA acknowledged that the report “confirmed that differences in communication, policies, practices, systems and application types can be challenging when the Centers work together on a review of a combination product.”
The report makes five recommendations:
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“Recommendation 1: Establish clear guidance for the review of common combination product types.”
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“Recommendation 2: Create new simplified processes for access to CDER’s Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) and CDRH’s Image 2000 for consulting reviewers; this access should be pre-approved, expedited, and long-lasting.”
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“Recommendation 3: Update the Intercenter Consultative/Collaborative Review Process Standard Operating Procedures and Policies (SOPP) Manual and Intercenter Consult Request form and make them easily accessible on the OCP website.”
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“Recommendation 4: Create and maintain a combination-product-specific organizational chart and contact directory, keeping personnel changes current.”
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“Recommendation 5: Establish a mechanism for estimating time spent on intercenter consults so resources can be allocated appropriately to organizational units to assure adequate review performance.”
In the cover memo to the report, Deputy Commissioner Robert Califf (and Commissioner nominee) endorsed the report and its recommendations and directed agency centers and offices to work to implement the recommendations.
FDA also noted that several actions consistent with the recommendations in the report are already underway or planned, including:
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Issuing more guidance for the review of combination products (e.g., a pending draft guidance document on human factors testing).
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Enhancing and simplifying data access and sharing for internal agency staff.
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Making it easier for agency staff to request and monitor intercenter consults.
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Updating and maintaining the agency’s internal contact directory for experts to review a combination product.
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Improving the agency’s internal standard operating procedures for premarket reviews and compliance activities.
While there is no timetable for FDA completing these actions, the Office of Planning’s report may bring increased attention to this issue and, we hope, may spur agency action to improve the review process for combination products.
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