OMB Individually Reported
Medical Data Enterprise Artificial Intelligence (MDE AI)
Low riskExact public inventory row
Description
Create efficiencies in the regulatory review processes for medical devices; reduce administrative burden to staff and allow them to focus their expertise on scientific and clinical work and not administrative processes
Detailed example
Outputs support regulatory review and include deficiency text adherence to 4PH, insights to support premarket review, data integrity concerns, signal alerts, etc.
AI / analytics pattern
Generative AI: AI that generates new or synthetic content (e.g., images, videos, audio, text, code).
Automation level / stage
b) Pilot – The use case has been deployed in a limited test or pilot capacity.
Expected benefit
Improved efficiency in the administrative overhead of regulatory review workflows
Controls / human review
ATO: Yes; PIA: Not published
Data needed
Labeled data sets of FDA-specific premarket and postmarket data