Concept: Opportunities for CDRH EPI Registry group

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Opportunities for DDOD as identified by FDA/CDRH's EPI Registry group in March 2015:

1. Master plan of integrating real world experience with initial device specifications and failure mode effects analysis

2. Improve access to FDA data

3. FDA data for device purchasing support

4. Improvements in FDA recall data sharing

5. Improve communication around consent decrees

6. Connecting warning letter data to health care impact and actionable items