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 efficacy evaluation
• Materials, performance, bioeffects and standards
• Adverse events

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 deadline for 2014 Internship & Fellowship positions is December 1, 2013.

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 8, 2013 at the Clark Center, Room S363 from 5:30pm till 6:30pm. Pizza will be served.

About CDRH

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.
Overview

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

1. Study relevant FDA regulations and legislation
2. Understand the types of applications (PMA, IDE, 510(k)) submitted for review.
3. Participate in meetings with device companies.
4. Participate in review/consult process.
5. Develop responses to industry.
6. Understand roles and responsibilities of federal advisory committees.

Give students exposure to clinical research issues from a regulatory perspective. Students will

1. Participate in developing clinical trial design with a device sponsor (company).
2. Define outcomes for a specific clinical trial design.
3. Analyze completed clinical trial data
4. Participate in preparing and presenting information to advisory committees.
5. Participate in approval decision process

Teach students the concept of medical device “total product life cycle” from a regulatory perspective. Students will

1. Participate in pre-market review of device submissions.
2. Learn about adverse event reporting and post-market evaluation of devices.
3. Learn how post-market evaluation informs pre-market decisions
4. Be exposed to CDRH laboratory research and testing

Provide classroom training. Students will be able to participate in

1. Didactic coursework, lectures, science seminars
2. CDRH Staff College courses (writing, leadership, time management, etc.)

Two oppurtunities to Participate in Medical Device Fellowship Program:

1. Internship (8-10 weeks) [only for current/continuing students]
2. 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.

Selection Criteria

• 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

Logistics

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 amattison@stanford.edu.