FDA Fellowship - Strategic Modernization of Regulatory Taxonomy: Energy Based Surgical Devices

Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CDRH-2026-0023
How to Apply

To submit your application, scroll to the bottom of this opportunity and click APPLY.

A complete application consists of:

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.

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Application Deadline
9/30/2027 3:00:00 PM Eastern Time Zone
Description

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), located in Silver Spring, Maryland.

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: To optimize Total Product Life Cycle (TPLC) oversight, strategic structure in categorization needs to be developed and implemented for these medical device types. You will conduct a comprehensive evaluation of current devices, assessing their underlying technologies, evolving clinical indications, and distinct benefit-risk profiles. Utilizing this analysis, you will architect a novel hierarchical classification scheme and develop a targeted strategy to parse the legacy categories into entirely new, specific, and benefit/risk-based product codes. This initiative will directly enhance the center's ability to track technological trends, streamline premarket reviews, and strengthen post-market surveillance.

Learning Objectives: Under the guidance of a mentor, you will:

  • Learn to support optimization of Total Product Life Cycle (TPLC) oversight for medical devices through strategic categorization efforts.
  • Gain experience conducting comprehensive evaluations of existing devices, including their underlying technologies, evolving clinical indications, and distinct benefit-risk profiles.
  • Develop skills in designing hierarchical classification schemes to improve regulatory organization and clarity.
  • Learn to create benefit/risk-based product codes by systematically restructuring legacy device categories into more specific groupings.
  • Contribute to initiatives that enhance the Center’s ability to track technological trends, streamline premarket review processes, and strengthen post-market surveillance activities.

Mentor: The mentor for this opportunity is Cal Rabang (cal.rabang@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentors.

Anticipated Appointment Start Date: October 12, 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.

Qualifications

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in the one of the relevant fields. 

Point of Contact
Eligibility Requirements
  • Degree: Master's Degree or Doctoral Degree.
  • Discipline(s):
    • Engineering (29 )
Affirmation

I am a U.S. citizen, or 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.) 

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