Summary of: Alliance webinar with CDRH Director Dr. Jeffrey Shuren
Dr. Shuren addressed the Alliance for a Stronger FDA this week. An audio copy of the program is here. His remarks are briefly highlighted below.
Lessons Learned – Regulatory flexibility and leveraging emergency use authorization was key to 2020. This flexibility should be continued and available all the time. He emphasized that this does not mean changing approval standards, but just how those standards are met.
Budget – The budget for CDRH has not kept up with demand. The Center is resource strapped. Devices are not cookie cutter, so a variety of capabilities are needed.
Staff – Current staffing levels are not enough to meet CDRH’s responsibilities. Also, new kinds of people are needed, and there is a need to be able to pay more. The CURES pay scale should be across FDA, along with sufficient funding and support for telework and professional development. Work-life balance matters as well if the staff are to be productive.
Regulatory Framework. At several points, Dr. Shuren pointed to the regulatory framework for devices as outdated. It is 45 years old, and it does not work with new technologies.
Device Shortages and Supply Chain Issues. Dr. Shuren pointed to the need for a permanent device shortage program, for which there has never been funding. During the pandemic, they had to reassign 130 people to get the device shortage and supply chain work done. For this they did receives some pandemic funding.
Safe and Effective Digital Health Technology – The Center needs to build out its efforts and collaborate more with stakeholders. However, innovation is being hurt by an outdated regulatory framework.
Cyber Security Threat – Cyber security is crucial. It is increasingly important with wireless devices and because of the threats from ransomware and other system vulnerabilities. Cyber security needs to be built in, not provided after the fact. Legacy software is a particular challenge. FDA is partnering with the National Institute of Standards and Technology (NIST) and will also be seeking new authority.
New Regulatory Science – There is a need for graded tools that can be used by product developers. He spoke about the Medical Device Innovation Consortium, and partnerships with the private sector.
Data Modernization – A big push in the President’s budget request is for funding for data and technology modernization at the agency. A more effective and efficient FDA is a tremendous benefit to patients and consumers, yet the effort is held back by the Center’s systems, calling them “clunkers” and “not connected”. Meantime, CDRH cannot make optimal use of the data. He talked about the Digital Transformation Initiative started in 2015, and the Customer Collaboration Portal that CDRH would like to develop and how it would benefit both users and FDA.
Dr. Shuren’s presentation was the fifth in the Alliance’s 2021 speaker series. For information about past and future programs, contact Steven Grossman at sgrossman@strengthenfda.org.
