FDA’s 2017 Priorities Emphasize Biomarkers and Precision Diagnostics

Precision medicine and biomarkers can help the U.S. Food and Drug Administration (FDA) ensure safety of medical devices. That’s according to the FDA Center for Devices and Regulatory Health’s (CDRH) Fiscal Year 2017 regulatory science priorities.

The agency says these priorities “help focus the Center’s attention on the most important regulatory science gaps or needs.” The priority most relevant to the diagnostics sector is an emphasis on using precision medicine to improve device review and monitoring and predict device-drug interactions.

“Development of clinical diagnostic assays, software and other tools that promote standardization of in vitro tools for a precision medicine approach that predicts clinical performance are necessary to expedite the use and to improve the quality of medical devices,” according to the CDRH. Additionally, “[c]haracterization data of existing samples and analytes is needed where no agreed-upon reference standards exist.”

Further, the agency emphasizes the importance of biomarkers for diagnosing mild forms of trauma and early stage disease to take advantage of “critical therapeutic windows.”

Other items on the FDA list of priorities include:

• Using Big Data to assist in regulatory decision-making
• Improvements to clinical trial design
• Increase medical device cybersecurity and advance digital health
• “Advance tests and methods for predicting and monitoring medical device clinical performance.”

The full document addressing the CDRH’s priorities for 2017 can be found on the FDA website.