FDA Internship & Fellowship
The U.S. Food & Drug Administration’s Center for Devices and Radiologic Health (CDRH), in partnership with the Stanford Biodesign Program, is seeking Stanford students interested to learn more about the medical device regulatory process and the journey a technology travels as it progresses from the lab workbench to a patient. The fellowships provide a unique opportunity to learn about the FDA approval process for medical devices, including topics such as:
- Medical device design
- Clinical trial design
- Safety and effectiveness evaluation
- Materials, performance, bioeffects and standards
- Adverse events
- Coverage, coding, and payment processes
- Outcomes assessment
- Budget impact analysis
Graduate and undergraduate students, postdoctoral candidates and postdocs from engineering (mechanical, electrical, software, and others) and life sciences (biological sciences, medicine and clinical specialties) areas are encouraged to apply. Students must have completed a minimum of three quarters of their college education and must be a current student attending Stanford or have just graduated in the same year as the internship or fellowship.
The application deadline for 2013 Internship & Fellowship positions is Dec. 14, 2012.
Fellowship applications will be processed through the Stanford Biodesign Program.
To learn more about this opportunity please join us for an informational session on October 31, 2012 at the Clark Center, Room S360 from 6:00pm till 7:00pm.
Pizza will be served.
Here is the slides from our Oct 31, 2012 Information Session:
CDRH is a center within the U.S. Food & Drug Administration which
regulates a wide array of medical devices, from artificial hearts, pacemakers,
and drug-eluting stents; to deep brain stimulators and spinal implants;
dialysis machines and infusion pumps; intraocular lenses and cochlear
implants; robotic surgery devices and stair-climbing wheelchairs; to in
vitro diagnostic devices, and many others. To keep pace with the rapid
development of new technology, and to make decisions based on the best
scientific information and knowledge available, CDRH routinely consults
with experts in the academic community, other government entities, clinical
practice, and the military.
CDRH established the Medical Device Internship and Fellowship Program to increase the range and depth of collaborations between CDRH and the outside scientific community. The MDFP offers short and long-term fellowship and summer internship opportunities for individuals interested in learning about the regulatory process and sharing their knowledge and experience with medical devices from the relatively simple to the highly complex.
Objectives of the Program
CDRH will provide a regulatory clinical science rotation for students interested in gaining exposure to clinical trial design and data analysis. Each student will be assigned a CDRH mentor and will work alongside clinicians, engineers, and other scientists in the medical device regulatory process. Fellowships are typically three-six months in duration, and may be extended when warranted. The minimum internship length is 8 weeks. 10 weeks or more are strongly preferred.
Specific objectives for the fellowship/internship are as follows:Teach students about the medical device approval process. Students will
- Study relevant FDA regulations and legislation
- Understand the types of applications (PMA, IDE, 510(k)) submitted for review.
- Participate in meetings with device companies.
- Participate in review/consult process.
- Develop responses to industry.
- Understand roles and responsibilities of federal advisory committees.
Give students exposure to clinical research issues from a regulatory perspective. Students will
- Participate in developing clinical trial design with a device sponsor (company).
- Define outcomes for a specific clinical trial design.
- Analyze completed clinical trial data
- Participate in preparing and presenting information to advisory committees.
- Participate in approval decision process
Teach students the concept of medical device “total product life cycle” from a regulatory perspective. Students will
- Participate in pre-market review of device submissions.
- Learn about adverse event reporting and post-market evaluation of devices.
- Learn how post-market evaluation informs pre-market decisions
- Be exposed to CDRH laboratory research and testing
Provide classroom training. Students will be able to participate in
- Didactic coursework, lectures, science seminars
- CDRH Staff College courses (writing, leadership, time management, etc.)
Two oppurtunities to Participate in Medical Device Fellowship Program:
- Internship (8-10 weeks) [only for current/continuing students]
- Fellowship (3 to 12 months) [for grad students and recent grads]
Who Should Apply?
Undergraduate students, graduate students, postdoctoral candidates and postdocs from all engineering and life sciences (biological sciences, medicine, surgery and clinical specialties) academic disciplines are encouraged to apply. Undergraduate students must have completed a minimum of three quarters of their college education and must be a current student attending a college or university in the US or have just graduated in the same year as the internship or fellowship. Graduates and postdocs must be currently attending a college or university.
Candidates must be U.S. citizens or permanent residents.
See a list of previous FDA fellows.
- Free from conflict of interest
- Relevant academic and/or work experience
- Demonstrated skill
- Ability to collaborate and work with others
- Ability to communicate orally and in writing
- Ability to handle deadline pressure
- Match between preferred medical device areas and current CDRH project activity
This is a full-time paid fellowship based in Washington DC. The Biodesign Program will cover your airline ticket to Washington and back. Selected applicants will be enrolled for up to 8 units per quarter during their time at the FDA and Biodesign will pay your tuition and insurance coverage through Cardinal Care. The selected student will need to enroll in one of the following courses under instructor Jan Pietzsch, Ph.D. in MS&E:
At the graduate level
MS&E 408 - Sec 35
Directed Reading & Research
At the undergraduate level
MS&E 101 - Sec. 35
Undergraduate Directed Study
At the end of each quarter you spend at the FDA you will be required to write a short report about what you did and what you learned during your time there in order receive a grade for the course. Please email all reports to firstname.lastname@example.org.
Please use the guidelines listed above in preparing and submitting the application materials. Mark all documents with you full name.
Application Process & Timeline
Stanford University students interested in applying to the CDRH Medical Device Fellowship/Internship Program should follow the application guidelines and instructions. Under the direction of Jan Pietzsch, Ph.D., the Stanford Biodesign Program will provide a preliminary application review. A brief interview may be required. Applications will then be forwarded to CDRH.
Deadline for submission of all application materials for the 2013 Internships and Fellowship is December 14, 2012.
Please make sure that all application materials are emailed before the deadline. Selection and interviews will be conducted in late January and early February.
What to Submit
|Cover Letter and Resume/Curriculum Vitae, including||Area(s) of expertise, description of
If currently employed (includes consulting), please provide a conflict of interest statement. See Conflict of Interest information.
If applicable, list existing intellectual property (filed or issued provisional or non-provisional patents). List number(s) and title.
Citizenship. If foreign, please include your VISA designation & status.
|Three Letters of Recommendation, at least one from an Academic Advisor||
Email pdf to
or mail originals to
|Statement of Interest, including||Current academic status, including any current employment. Example: Dept. of Mechanical Engineering, 2nd year Master’s student. Design Engineer at IDEO Product Design firm (Palo Alto, CA).|
|Project Statement||Briefly describe a project or area
of investigation that you would like to explore during
Indicate two (2) Preferred Medical Device Areas for study (see below).
|Availability for Fellowship||individualized|
|Academic Transcripts||Both copies and original transcripts will be accepted.
Original documents should be addressed to:
Medical Device Areas
|General, Restorative & Neurological||
|Ophthalmic & ENT||
|Reproductive, Abdominal, & Radiological||
Anesthesiology, General Hospital, Infection Control, & Dental
|In Vitro Diagnostic||
Important. Read Before Applying
Part-time student enrollment & student loans: Selected applicants will be enrolled at Stanford as a part-time student during their fellowship period. Loan repayment for some student loans is activated once a student changes to part-time status. We strongly encourage all applicants to review the terms of their student loans.
Foreign students: Unfortunately, candidates must be US citizens or permanent residents.
The Stanford Biodesign Program is administering the Medical Device Fellowship and Internship Program in partnership with the FDA’s Center for Devices and Radiological Health. Please contact the Biodesign Program if you have questions about the application process through Stanford University.
For general information about the CDRH Medical Device Fellowship Program, please see http://www.fda.gov/cdrh/mdfp/.
Stanford Biodesign Program
Stanford, CA 94305-5428