FDA Artificial Intelligence and Machine Learning Fellowship
To submit your application, scroll to the bottom of this opportunity and click APPLY.
A complete application consists of:
- An application
- Transcripts – Click here for detailed information about acceptable transcripts
- A current resume/CV, including academic history, employment history, relevant experiences, and publication list
- One educational or professional recommendation
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CDRH@orau.org / . Please include the reference code for this opportunity in your email.
Connect with ORISE...on the GO! Download the new ORISE GO mobile app in the Apple App Store or Google Play Store to help you stay engaged, connected, and informed during your ORISE experience and beyond!
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: Up to 14 research fellowships are available with the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) located in White Oak, Maryland.
Oak Ridge Institute for Science and Education (ORISE) Research Participation Programs at the U.S. Food and Drug Administration are educational training programs designed to provide students and recent graduates, opportunities to participate in project-specific research and developmental at the Center for Devices and Radiological Health (CDRH). The mission of CDRH is to protect and promote public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH provides consumers, patients, caregivers, and providers with understandable and accessible science-based information about products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
Research Project: The Artificial Intelligence Regulatory Science Program conducts regulatory science research ensuring safe and effective AI/ML-enabled medical devices across rapidly expanding healthcare applications including image processing, disease detection, diagnosis, and therapeutic monitoring. The program addresses critical regulatory challenges posed by AI devices that can continuously learn and adapt, including the unique nature of clinical medical data with low disease prevalence and difficulty obtaining ground truth data. Major regulatory science gaps include lack of methods for AI algorithm training with limited data, bias analysis and minimization, performance metrics and uncertainty quantification, evaluation of continuously learning algorithms, and post-market monitoring.
Learning Objectives: Under the guidance of an FDA mentor, you will:
- Gain comprehensive understanding of regulatory science approaches for AI/ML-enabled medical devices, including performance assessment methodologies and uncertainty quantification methods.
- Acquire specialized skills in addressing critical data challenges in medical AI, including methods for training algorithms with limited datasets, synthetic data evaluation, and approaches to minimize algorithmic bias.
- Develop expertise in evaluating AI devices that can adapt and learn post-deployment, including understanding evolving algorithms and creating methodologies to assess algorithm performance changes over time.
Mentor: The mentor(s) for this opportunity are Ravi Samala (ravi.samala@fda.hhs.gov) and Aldo Badano (aldo.badano@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor(s).
Anticipated Appointment Start Date: Spring 2026. Start date is flexible and will depend on a variety of factors.
Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
Level of Participation: The appointment is full time.
Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience.
Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
The qualified candidate should have received or be currently pursuing a master's or doctoral degree in the one of the relevant fields.
I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
ORISE GO
The ORISE GO mobile app helps you stay engaged, connected and informed during your ORISE experience – from application, to offer, through your appointment and even as an ORISE alum!
