Last December, GAO was asked to provide information on how FDA www.fda.gov plans to implement a less burdensome approach to their medical device review process. The GAO report is titled “Evaluation is needed to Assure Requests for Additional Information Follow a Least Burdensome Approach” https://www.gao.gov/assts/690/689065/pdf.
GAO is making one key recommendation that FDA develop and use performance metrics to evaluate the implementation for the least burdensome requirements. HHS agrees with GAO’s recommendation
FDA Commissioner Scott Gottlieb, MD., in response to the GAO study, overall agrees that an effective and a less burdensome approach is needed to evaluate novel devices under review. Recently, new steps were taken to advance and expand this approach.
He reports, “For example, we’ve been expanding the use of real world data gathered as part of the process in providing clinical care such as making use of the information found in EHRs and patient registries.”
FDA is also using a total life cycle approach to device regulations that includes pre-market as well as post-market data collection. According to Commissioner Gottlieb, “Using real world data can make it easier to understand device benefits and risks and can reduce the time and cost for bringing safe and effective new devices to patients.”
As reported, FDA is encouraging earlier and more frequent interaction between the FDA and manufacturers in order to help bring state-of-the-art technologies to market faster.
FDA has also qualified the first medical device development tool to provide more efficient and accurate ways to measure benefits and risks early in the process for building and testing a new medical device. FDA has already trained more than 90 percent of their staff on the requirements and plans to complete an audit of this training by June.
Recently, FDA issued a new draft guidance clarifying how FDA intends to implement and go beyond additional provisions enacted in the 21st Century Cures Act. This includes assessing the minimal amount of information necessary for assuring the safety and effectiveness of new devices.
The FDA has outlined some different pathways for manufacturers in order to take part earlier in the development process. For example, with some of the new modalities such as gene therapy and regenerative medicine where there is uncertainty, FDA is encouraging biotech firms to engage with FDA early on to get feedback on how to design early stage development programs.
Dr. Gottlieb reports, “We well be releasing a new medical device safety action plan as part of our 2018 Strategic Policy Roadmap. We are also going to advance new ways to provide more transparency to patients who want information on the risks and benefits of a device before determining whether to use it for a crucial medical treatment.”