CDRH Outlines Regulatory Science Priorities for 2017


The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the arm of the Food and Drug Administration that oversees medical devices intends to focus on leveraging “big data” for regulatory decision making and modernizing biocompatibility and biological risk evaluation of device materials, according to its list of regulatory science priorities for the upcoming year.

Regulatory science “helps ensure that regulatory decisions are well-founded and achieve the desired impact on public health,” the Center for Devices and Radiological Health (CDRH) wrote in its 13-page report. “It facilitates good decision making in the areas of premarket evaluation, post-market surveillance, compliance, and communication.” This year, increased outreach within the center yielded new topic areas of focus, such as clinical trial design and precision medicine, and provided greater detail for existing topics.

CDRH’s top 10 priorities for 2017 are:

- Leveraging “big data” for regulatory decision making.

- Modernizing biocompatibility and biological risk evaluation of device materials.

- Leveraging real-world evidence and employing evidence synthesis across multiple domains in regulatory decision making.

- Advancing tests and methods for predicting and monitoring medical device clinical performance.

- Developing methods and tools to improve and streamline clinical trial design.

- Developing computational modeling technologies to support regulatory decision making.

- Enhancing the performance of digital health and strengthening medical device cybersecurity.

- Reducing healthcare-associated infections by better understanding the effectiveness of antimicrobials and the sterilization and reprocessing of medical devices.

- Collecting and using patient input in regulatory decision making.

- Leveraging precision medicine and biomarkers for predicting medical device performance, disease diagnosis, and progression.

CDRH acknowledged in its report that “although the area of human factors is not prominently identified as a priority, it is still an unmet need and is reflected in the descriptions of other FY 2017 top 10 priorities (e.g. infection control and predicting medical device clinical performance).”

Source: AAMI

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