FDA, Industry Flesh Out Details Of MDUFA IV

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) and medical technology industry representatives continue to negotiate over salient topics concerning the next five-year reauthorization of the Medical Device User Fee Act (MDUFA).

MDUFA is the agreement between FDA and medtech companies designed to facilitate device reviews in exchange for user fees collected from device sponsors. It was renewed through legislation in 2007 and 2012, and the ongoing negotiation aims to reauthorize the user fee program under MDUFA IV in 2017. Related, FDA has hosted a series of public meetings since September 2015 to discuss with industry representatives their proposals.

During the January 20 meeting, FDA, based on projected workload and target performance levels, estimated that additional resources to implement industry proposals over the next five years under MDUFA IV would total $456.4 million. That's exclusive of the amount of user fees needed to maintain the level of staffing and activities currently supported by MDUFA III. During this meeting, instead of forming separate working groups, FDA and industry held several working discussions of the details of the proposals.

In the January 27 meeting, FDA presented an integrated proposal, combining elements of the agency's and industry's proposals from past meetings.

Review Oversight

FDA proposed adding 20 full-time employees (FTEs) to increase the capacity of Branch Chiefs to provide greater oversight of review procedures, to oversee appropriateness and quality of deficiencies, and to allow Branch Chiefs the time for increased interactions with industry (i.e., through longer pre-submission meetings.)

Quality Management (QM)

FDA suggested hiring 20 FTEs — 16 for Office of Device Evaluation (ODE) and 4 for the Office of In Vitro Diagnostics and Radiological Health (OIR) — to establish a Quality Management (QM) team composed of a director and two branches. One branch would be designated for QM and operational excellence, and the other for measuring and monitoring quality through metrics development and analysis, program audits, and reporting. FDA said that a QM team would result in more consistency and efficiency, as recommended by an independent assessment from consulting firm Booz Allen Hamilton.

IT Modernization

FDA briefly discussed the development of the myDevices Portal and eSubmitter within a cloud-based portal that would enable electronic submissions, structured data, and streamlined tracking. FDA and industry agreed to discuss more about this topic in subsequent meetings.

Integrated Review Process

FDA proposed shifting some compliance and surveillance activities into ODE to achieve a more integrated review process by the end of MDUFA IV. FDA estimated that eight FTEs would oversee newly integrated activities, and six FTEs would be assigned for program operations staff to establish procedures, as well as to provide processes and tools to promote consistency.

Device Coordinators

Because reviewers and managers are under increasing pressure to meet performance goals, FDA proposed to hire 43 FTEs as device coordinators, who would take on some of reviewers' responsibilities. Specifically, coordinators would be tasked to ensure consistency in process and feedback for devices to be reviewed through the premarket approval (PMA) or de novo pathways.

De Novo

FDA originally proposed a target wherein 70 percent of de novos would receive a decision within 120 days by the end of MDUFA IV. The Advanced Medical Technology Association (AdvaMed), the Medical Device Manufacturers Association (MDMA), and the Medical Imaging & Technology Alliance (MITA) had been pushing for 90 percent of de novos to receive a decision withinin 120 days, starting in the first year of MDUFA IV. Citing the impracticality of industry's target, FDA suggested a revised mark of 80 percent of de novos within 120 days by the final year of MDUFA IV.

Third-Party 510(k) Review

FDA plans to strengthen the third-party review program by training third parties, providing redacted example reviews, auditing third parties, removing incompetent third parties, and tailoring the program to allow review of some submissions with clinical data. FDA proposed steadily improving performance targets that would achieve decisions on 85 percent of third-party 510(k)s within 30 days by the end of MDUFA IV.

CLIA Waiver

FDA proposed the following goals for CLIA waiver by application submissions by the fourth year of MDUFA IV: 90 percent of dual 510(k) and CLIA waiver by application submissions would receive a decision in 180 days; 90 percent of stand-alone CLIA waiver by application submissions without panel meetings would receive a decision in 120 days; and, 90 percent of CLIA waiver by application submissions with panel meetings would receive a decision in 320 days.

Digital Health

In the area of digital health, FDA proposed to streamline and align FDA processes with software lifecycles, and to conduct a systematic, end-to-end evaluation and optimization of medical device software regulation. FDA also offered to interact with sponsors earlier in the software development lifecycle to support software design and architecture decisions.

Device-Specific Guidance

In response to industry groups’ request for more device-specific guidance, FDA proposed to hire 12 FTEs who would be primarily technical writers to produce high quality device-specific guidance documents more efficiently, and to shift subject matter experts more towards doing premarket reviews.

Leveraging Standards

FDA proposed an accreditation certification body (CB) program for conformity assessment of FDA-recognized consensus standards. The agency plans to work with testing labs and accreditation bodies to help manufacturers follow those standards in their premarket applications.

Real World Evidence (RWE)

FDA proposed a system that links and improves the regulatory quality of real-world evidence data sources, such as data from electronic health records, healthcare claims, and registries.

Industry, however, raised concerns about the use of claims data because off-label use or use by clinical staff without appropriate training for the device could yield data that would be difficult to use for the proposed purpose, according to RAPS. FDA said its plan would address those issues.

Patient Input

FDA proposed to train staff on conducting efficient and effective review submissions that contain patient preference information (PPI) and patient reported outcomes (PROs), and how to write guidance documents about the same. It also proposed to meet with sponsors to teach them on how they can incorporate PPI and PROs in their submissions.

FDA and industry representatives agreed to further discuss aforementioned proposals and similar topics at their next negotiation meeting, slated to take place Feb. 18, 2016.