Game-Changing Medical Device Priorities Need Funding

Until we have the budget-in-detail for FDA (also known as the CJ or Congressional Justification), we have relied on Commissioner Gottlieb’s statement on “Administration’s request for new FDA funding to promote innovation and broaden patient access through competition.” At his meeting with the Alliance, Dr. Shuren reviewed the programs in the budget request that would be led by CDRH and which represent the Center’s four priorities for investment.

Real World Evidence (RWE): A key FDA priority is obtaining better clinical evidence and to do so more efficiently. For medical technology, RWE can fill gaps in the data that FDA relies upon for pre-market evaluation of devices and continued monitoring of post-market safety.  Unlocking RWE would not only expand the efficiency of the regulatory process, but also allow patients and providers to have information about pre-and post-market safety, and reduce burdens on data collection for new innovations.Dr. Shuren highlighted FDA’s establishment of the National Evaluation System for Health Technology (NEST), which collects data across the medical device landscape, including clinical registries, and electronic health records. NEST, which has both public and private funding, needs additional investment, including an infrastructure buildout to develop data and analytical tools for more efficient recognition of safety concerns.

Quality and Advanced Manufacturing: With regard to medical technology manufacturing, CDRH’s goal is to foster intelligent manufacturing technology in the U.S., while increasing the safety of medical devices. FDA’s current Quality System Regulation (QSR) for medical devices, although effective in assuring the manufacturing of safe and effective devices, is constrained and does not allow manufacturing processes to be changed easily, ultimately disincentivizing innovation in manufacturing.CDRH is developing a new paradigm, whereby manufacturer would receive a certification to allow for a more flexible manufacturing environment. Per Dr. Shuren, the new paradigm would be a voluntary program that is a surrogate to the QSR. CDRH is currently working with stakeholders through the Medical Device Innovation Consortium to develop the parameters of the program.

Digital Health Framework: The current regulatory framework for digital health is outmoded. FDA has been working with stakeholders to develop a risk-based model that allows digital health products to move to market more efficiently. For lower risk digital health products, a company would be able to market without pre-market review or approval. For higher risk digital health products, a company would be able to market through a streamlined process if the company receives a precertification.Two additional benefits of an improved regulatory framework would involve better access to post-market data and the opportunity to focus more on the cybersecurity issues inherent in digital health. Among other things, funding would help FDA support a public/private community that the industry could use as a resource to share information to help identify cyber vulnerabilities.

CDRH Information Technology Systems: Dr. Shuren added that funding is needed for CDRH’s own information technology, highlighting a number of areas that require modernization. Notably, CDRH has data that is difficult to use and analyze due to inefficient systems and CDRH particularly needs updated systems for digital health and RWE. He envisions that upgraded IT will also enable better interaction with stakeholders.In closing, Dr. Shuren stated that FDA’s base funding is not adequate to achieve these objectives.  The agency has done much of the leg work already, but CDRH will not see fruits of this work until it has the additional funding necessary to implement the above “game-changing” priorities.

Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.