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.
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