Here are the 10 priorities the agency will focus on in the upcoming year, according to the report.
- Use “Big Data” for regulatory decision-making.
- Update biocompatibility and biological risk evaluation of device materials.
- Use real-world evidence and engage evidence synthesis across multiple domains in regulatory decision-making.
- Improve tests and methods for predicting and monitoring medical device clinical performance.
- Develop methods and tools to improve and streamline clinical trial design.
- Create computational modeling technologies to support regulatory decision-making.
- Enhance the performance of digital health and strengthen medical device cybersecurity.
- Better understand the effectiveness of antimicrobials, sterilization and reprocessing of medical devices to reduce healthcare-associated infections.
- Collect and consider patient input in regulatory decision-making.
- Rely on precision medicine and biomarkers for predicting medical device performance, disease diagnosis and progression.
More articles on supply chain:
Negotiated price of Medicare Hep C treatments lower than countries with set pricing system
FDA official explains difficulty of approving generic EpiPen at Senate hearing
Supply chain tip of the week: Stick to facts not feelings