CDRH & Regulatory Science
According to CDRH, regulatory science is aligned with and supports both its mission and vision. In addition, the Center states that it feels regulatory science “must be proactive and anticipate regulatory and public health issues, while also being responsive to emergent issues.”
The Center’s “regulatory science priorities serve as a catalyst to improving the safety, effectiveness, performance and quality of medical devices and radiation-emitting products and to facilitate introducing innovative medical devices into the marketplace.” These priorities are identified on an annual basis and are reassessed and updated periodically to reflect the current needs. Furthermore, CDRH states that its regulatory science priorities are intended to serve as a guide for making strategic decisions regarding intramural research funding. This helps to “ensure that CDRH research is focused on needs that are relevant and critical to medical devices and radiation-emitting products.”
Determining the Regulatory Science Priorities for 2017
Using the feedback provided from CDRH staff and senior leadership, the 2017 priorities were identified by the Regulatory Science Subcommittee (RSS) under the direction of the Center Director and the RSS co-chairs. CDRH states that it used the following approach in developing its priorities:
- “Regulatory science needs collected in FY2015 were combined with the ones we identified in FY2016.
- Regulatory science needs were clustered according to their affinity.
- The individual needs and their general categories were scored using a set of criteria described below.
- The proposed top ten priorities were reviewed and approved by our senior leadership and Center Director to ensure alignment with our Center’s and Agency’s priorities.”
In addition, the Center also notes that the “regulatory science needs were assessed for their regulatory and public health impact using the following criteria:
- Will addressing the need facilitate medical device innovation and bring new technology to market?
- Will addressing the need enhance or expedite the availability of medical devices and radiation-emitting products while maintaining their safety and effectiveness?
- Will addressing the need facilitate rapid identification of problems, improve our postmarket understanding of the benefit-risk profile of devices or radiation-emitting products and aid future premarket device clearance or approval?
- What is the public health impact of the need?”
2017 Regulatory Science Priorities
The following are CDRH’s 2017 regulatory science priorities:
- Leverage “Big Data” for regulatory decision-making
- “Modernize biocompatibility and biological risk evaluation of device materials
- Leverage real-world evidence and employ evidence synthesis across multiple domains in regulatory decision-making
- Advance tests and methods for predicting and monitoring medical device clinical performance
- Develop methods and tools to improve and streamline clinical trial design
- Develop computational modeling technologies to support regulatory decision-making
- Enhance the performance of Digital Health and medical device cybersecurity
- Reduce healthcare associated infections by better understanding the effectiveness of antimicrobials, sterilization and reprocessing of medical devices
- Collect and use patient input in regulatory decision making
- Leverage precision medicine and biomarkers for predicting medical device performance, disease diagnosis, and progression
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