CDRH Releases FY 2017 Regulatory Priorities
Today CDRH issued its regulatory science priorities for FY 2017. The goal is to boost device safety and effectiveness, performance and quality. The priorities are:
- Use big data for regulatory decision-making
- Modernize biocompatibility and biological risk evaluation of device materials\
- Leverage real-world evidence and use evidence synthesis across multiple domains in regulatory decision-making
- Advance tests and methods for predicting and monitoring clinical performance of medical devices
- 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
- Strengthen medical device cybersecurity
- Reduce healthcare-associated infections by better understanding the effectiveness of antimicrobials, sterilization and reprocessing of medical devices
- Collect patient input for regulatory decision-making
- Leverage precision medicine and biomarkers for predicting device performance, disease diagnosis and progression
Related Articles
-
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
-
The FDA has updated the CDRH portal to allow users to track the progress of their pre-submissions. As of October 23, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using FDA’s eSTAR portal.
-
The voluntary program is designed to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.
-
Unhappy with current textbooks and resources for regulatory professionals, Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston Scientific, authored his own book for industry and future regulators.
