CDRH Commits to 3-Year Goal to Bring Novel Devices to the U.S. First

CDRH released a three-year plan outlining three priorities to focus on: employee engagement, streamlining of processes, and building “collaborative communities.”

The plan features a single goal to measure overall success. “As a measure of success, we aim to have more than 50 percent of manufacturers of novel technologies for the U.S. market intend to bring their devices to the U.S. first or in parallel with other major markets by December 31, 2020,” said CDRH Director Jeff Shuren.

The three priorities are aimed at achieving this goal, though it is not clear how the center will assess the intention of manufacturers of novel devices.

2018-2020 Priorities

The CDRH Engage Council is charged with overseeing implementation of the first identified priority: employee engagement, opportunity, and success.

The second priority is simplicity, which means streamlining processes, and programs, as well as removing unnecessary burdens.

CDRH also plans on applying the concept of “Collaborative Communities” through efforts such as its Case for Quality initiative that engages device firms, payers, and patients, among others. As part of this approach, the center will help establish the National Evaluation System for health Technology (NEST), the a multi-million dollar project initiated in 2016 to generate real-world evidence (RWE).

For fiscal year 2018, the agency awarded the NEST Coordinating Center a five-year cooperative agreement with $6 million in annual funding derived from user fee payments, supported in RWE commitments under the latest reauthorization of MDUFA.

To implement this priority, a cross-center Steering Committee will be created and tasked with developing a code of conduct and best practices for Collaborative Communities.

“We will make building Collaborative Communities our standard practice,” CDRH said. The center will also “consider whether a Collaborative Community approach could be adopted across two or more countries” by using the International Medical Device Regulators Forum as a catalyst.

CDRH has already started using the three approaches. Shuren pointed to the results with efforts that are underway. For example, the number of approved novel devices seeing a four-fold increase from 29 in 2009, vs. 95 in 2017, reaching “an all-time high during the user fee era,” Shuren said (IDDM, Jan. 15).

2017 Highlights

In a separate report, the center said it exceeded its targets for 2017, including gaining access to 100 million electronic patient records by using device identification (result: 103 million records); an increase of 100 percent in the number of pre- and post-market regulatory decisions using RWE (result: 193 percent); and engaging with 20 patient groups since 2016 (result: 48 patient groups).

Last fall, the FDA issued final guidance encouraging the use of RWE for regulatory decision-making by providing clarifications on the factors that should be used by industry and agency staff to determine whether the real-world data collected can be used as RWE for this purpose (IDDM, Sept. 4, 2017).

Another 2017 target involved proposing a voluntary industry program aimed at improving product and manufacturing quality by year’s end. In December 2017, the center announced its plan to begin accepting applications for the voluntary Case for Quality Pilot Program by Jan. 2. The program is aimed at identifying best practices and enhancing resource allocation for potential cost savings with the help of no more than nine enrolled participants (IDDM, Jan. 8). — Ana Mulero