The FDA's Center for Devices and Radiological Health issued its regulatory science priorities for fiscal year 2017, according to HealthData Management. The fiscal year 2017 commenced Oct. 1.
Here are five insights:
1. The CDRH aims to ensure the safety, effectiveness, performance and quality of medical devices and radiation-emitting products.
2. The center highlighted health information technology as a major focus for 2017.
3. Key priorities include:
• Using big data for regulatory decision-making
• Creating methods to streamline clinical trial design
• Improving digital health and medical device cybersecurity
• Establishing computational modeling technologies to assist regulatory decision-making
• Gathering patient input in regulatory decision-making
• Using precision medicine and biomarkers to predict medical device performance
4. The center plans to "harvest, validate, organize and disseminate" information in data warehouses in order to streamline regulatory decision-making, according to HealthData Management.
5. Regarding cybersecurity, the CDRH has established new guidelines on how manufacturers should identify and lessen cybersecurity weak points once devices are in use.