FDA Releases Science Priorities for 2016
The Regulatory Science and Policy Subcommittee (RSS) recently released the top ten regulatory science needs. Annually, this subcommittee collects the reported gaps from the CDRH offices and uses this information to asses the following year’s regulatory science needs. Here’s a recap on what you need to know:
What is regulatory science?
FDA’s Center for Devices and Radiological Health (CDRH) uses regulatory science to target improvements in the assessment of safety, effectiveness, performance, and quality of medical devices (and radiation emitting products) to reduce time to market, improve safety, and to make the process least burdensome. Regulatory science specifically is the science of improving the regulatory foundation used when making regulatory decisions that impact patient safety.
To that end, CDRH formed the Regulatory Science Subcommittee (RSS) in 2013 specifically for “proactively enhancing medical device innovation, development, safety, quality and effectiveness through developing policies and practices that promote the identification and incorporation of new science and technology into regulatory decision making.” Their charter utilizes regulatory science in order to facilitate these changes.
What is the purpose of the Priorities?
CDRH uses the Regulatory Science Priorities to make research decisions to ensure that the most relevant and critical issues are focused upon such that regulatory science goals are obtained and creating favorable impact on public health and regulatory decision-making.
As a manufacturer of medical devices, the priorities illuminate where the FDA is focusing its attention relative to regulatory methodologies and future decisions. In other words, it shows where the FDA regulatory processes are headed in the future.
Okay, so what are the Priorities?
- Leverage “Big Data” for regulatory decision making
- Leverage evidence from clinical experience and employ evidence synthesis across multiple domains in regulatory decision making
- Improve the quality and effectiveness of reprocessing reusable medical devices
- Develop computational modeling technologies to support regulatory decision making
- Enhance performance of Digital Health and medical device cybersecurity
- Incorporate human factors engineering principles into device design
- Modernize biocompatibility / biological risk evaluation of device materials
- Advance methods to predict clinical performance of medical devices and their materials
- Advance the use of patient reported outcome measures (PROMs) in regulatory decision making
- Collect and use patient experience/preference in regulatory decision making
What does this mean?
Human factors are getting more attention. Devices that interface with humans will get increased scrutiny in their human factors considerations. ISO/TR 16982 will help manufacturers better understand how to incorporate these necessary factors into their products.
Looks like the “data” will be an increased focus, meaning the agency will intensify its efforts to gather and leverage data used to make regulatory decisions. This includes data used to release products to market as well as data used in post market evaluations. Increased availability of data will enable information exchange and improve regulatory control and correct decision making within the medical device industry.