Medical Data Enterprise Artificial Intelligence (MDE AI)
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 clinica…
COMET (Consult Memo Assistant)
Efficiency of the premarket regulatory review
Food AI Decision Engine (FAIDE)
Prioritize limited regulatory resources and maximize public health protection.
Warp Intelligent Learning Engine (WILEE)
Identify emerging chemical signals and violative food substances by analyzing a large data set in a fraction of the time that it would have taken scientific reviewers to analyze t…
Rapid Intuitive Pathogen Surveillance (RIPS)
Identify and prioritize incoming sources of potential foodborne outbreaks, maximizing public health by reducing the time burden on regulators.
AI-Powered Assistant for Pathogen Detection (AIPD)
The AIPD is designed to address several key challenges in data analysis for foodborne pathogens, such as accessibility barriers for data sources, manual workflow overhead, knowled…
Product Label and Text Extraction System (PLATES)
Manual food label data extraction causes slow data accessibility and insights. Manual data processing and standardization causes slow data accessibility and insights. Decentrali…
Data Ingestion and Content Explorer (DICE)
Multiple stakeholders across HFP have the business need to search for content within artifacts and documents uploaded to various systems. For systems like CARA and CARTS, document…
Smart Solution for Docket Management (SSDM)
The AI is intended to solve the extremely labor-intensive and time consuming process of manually collating, de-duplicating, and categorizing public comments on FDA dockets.
Elsa GenAI Chat Tool
Elsa is designed to support FDA employees by providing clear, accurate information and assistance with work-related tasks. Elsa's primary purpose is to help streamline information…
AI-Assisted Systematic Review and Validation of Analytical Worksheets
Manual review and validation of analytical worksheets can create bottlenecks in regulatory processes, introduces potential human error, and limits scalability of quality assurance…
AI-Generated Data Processing and Visualization Code Development
Manual coding for data processing and visualization creates barriers to AI adoption, requires specialized expertise not available across all teams, and limits agency ability to ma…
AI-Enhanced FDA Regulated Commodity Consumption Pattern Analysis
Traditional analytical methods for determining consumption patterns of FDA-regulated commodities are limited in scope and processing speed which hinders comprehensive market surve…
AI-Enhanced High-Dimensional Matrix Dataset Trend and Correlation Analysis
High-dimensional datasets present analytical challenges that exceed traditional statistical methods' capabilities, limits the ability to extract meaningful insights from complex r…
ChatBot for Safety Reporting Portal Adverse Events and Product problems submissions
Increases data integrity and aid with routing the user to the correct commodity group to submit their adverse event or product problem. DRUID AI, a COTS tool, boasts a comprehensi…
Machine Learning as a Service: Translate and extract text from images using AI
This AI project is designed to solve the problem of reviewing foreign products, extracting ingredient lists, and border inspections
Machine Learning as a Service: Extract data from product labels, business forms, and image files
This AI project is designed to assist in capturing data submitted to & reviewed by the FDA by extracting text and data, determining its structure, and saving the information in a…
Filer Evaluation prioritization using risk-based decision Machine Learning approach
The FDA's Office of Information Operations (OIO) has an opportunity to enhance its evaluation capabilities across over 4,000 filers in the current FDA inventory by implementing a…
Electronic translational services for regulatory documents for articles offered for import
FDA' Office of Information Operations (OIO) seeks to implement automated translation capabilities for foreign language documents essential to import operations. By integrating tra…
AI-Powered Video Analytics for Law Enforcement
The AI is intended to solve the challenge of manually reviewing large volumes of surveillance video, which is time-consuming, labor-intensive, and prone to human error.
Computer Vision to translate and mine Product Labeling photos to analyze labeling for potential violations
The intent is to reduce the amount of time import operations users spend reviewing product labeling of imported products for violations.
Intelligent Document Processing to analyze current import entry documentation for potential discrepancies
The intent is to assist in the process of discrepancy identification between documentation submitted by trade and CBP line data submitted.
AI Audit Resolution Assistant (AIARA)
The DFI PRF AIARA project leverages AI to streamline the single audit process. The team utilizes the Robotic Process Automation (RPA) to extract data from the Federal Audit Clear…
Knowledge Navigator
The objective is to develop an AI model that can answer detailed and complex questions about the key programmatic document, Application and Program Guidance (APG), that is issued…