The goal of this project was to strengthen the coordinated registry network as a real-world data source for high quality, relevant, reliable, timely and actionable evidence to improve patient outcomes of medical devices, specifically for technologies affecting women’s health. This was done by advancing their ability to capture standardized data, include patient generated data, and link their registry data to additional data sources.
Two examples of major accomplishments and products are:
- Through engagement of key stakeholders, FDA developed an innovative maturity framework for registries/CRNs using important aspects of infrastructure building in seven critical domains: unique device identification, patient engagement and patient reported outcomes (PRO), data quality, efficiency, governance, sustainability, and fitness for use during the total product life cycle. Mature CRNs as well as early CRNs participated in the assessment and found it beneficial to systematically evaluate their data infrastructure.
The framework is described in the recently published manuscript in BMJ-SIT
- Maturity framework and select approaches for developing Coordinated Registry Networks (CRNs): Medical Device Epidemiology Network (MDEpiNet) supplement | BMJ Surgery, Interventions, & Health Technologies
- In response to the growing body of evidence indicating that sex and gender may play significant roles in the course and outcome of condition and selected treatments, the CDRH Health of Women Strategic Plan identified 3 priorities to encourage innovations in the research of, device development, and dissemination of sex- and gender-difference studies. These priorities include (1) improving the availability, analysis, and communication of sex- and gender-specific information, (2) applying an integrated approach for current and emerging issues related to the health of women, and (3) developing a research roadmap for the health of women medical device ecosystem. FDA developed a framework for sex- and gender- specific studies where findings are used to improve CRN development and lead future research.
- Below are the example studies conducted using the CRN infrastructure:
 Food and Drug Administration: Center for Devices and Radiological Health. Evaluation of Sex-Specific Data in Medical Device Clinical Studies. Published online 2014:1-26. http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm283453.htm
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