FDA published its 2021 regulatory science report on Monday, noting that its efforts are prioritized across three strategic initiatives: unleashing the power of data, increasing choice and competition through innovation, and empowering patients and consumers. The 60-page report identifies the science and technology areas in which FDA plans to advance its thinking and practices as it responds to innovation from industry.
“The FDA conducts regulatory science research, which is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of certain FDA-regulated products,” said Rear Admiral Denise Hinton, FDA Chief Scientist. “Today, we released the Focus Areas of Regulatory Science (FARS) report, which outlines topics that the FDA has identified as needing continued targeted investment in regulatory science research to facilitate the development of innovative products, provide data and methodology to inform regulatory decision-making and improve guidance to sponsors.”
Unleashing the Power of Data
FDA notes that this initiative focuses on identifying and using reliable data sources, including complex data sets that require improved analytics and harness high-performance computing environments, and new computational tools based on machine learning (ML) and artificial intelligence (AI).
Specific to AI, FDA aims to improve its understanding of the technology’s potential and limitations, including technical and practical applications of AI and ML, regulatory questions introduced by using AI applications and the impact of AI across the lifecycle of regulated products.
FDA also prioritized digital health technologies that use computing platforms, digital connectivity, software and sensors. The Agency noted that as healthcare moves outside of the clinic, it’s crucial to understand how digital tools function and collect patient data.
Increasing Choice and Competition through Innovation
To support innovation that promotes choice and competition, FDA’s research addresses its knowledge gaps in understanding how new science and technology are applied to FDA-regulated products. Among innovation areas important to orthopedics are regenerative medicine and advanced manufacturing.
The report notes that regenerative medicine therapies pose regulatory challenges for FDA, particularly regarding how products are designed, sterilized and interact with different cells within the body.
FDA applies advanced manufacturing as a collective term for newer medical manufacturing technologies and processes. The Agency is currently engaged in research around additive manufacturing; smart manufacturing, including automation, digitization and artificial intelligence to streamline production, and point-of-care manufacturing, whereby hospitals are deploying additive manufacturing onsite to print devices.
Empowering Patients and Consumers
FDA had evolved and heightened its patient focus over the years, promoting paths for patients and consumers to share preferences and perspectives. The Agency continues to prioritize this feedback to select or develop tools to measure what matters most to patients and aid in how it communicates with the public.
The 2021 report doesn’t announce new FDA initiatives. Still, it does condense FDA’s science priorities, identifies questions it aims to answer and notes the research, tools and resources that orthopedic professionals can utilize to advance their thinking around products, processes and manufacturing.