ODE Intern Program

ORGANIZATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS)
FOOD AND DRUG ADMINISTRATION (FDA)
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
OFFICE OF DEVICE EVALUATION (ODE)
9200 Corporate Boulevard
Rockville, Maryland 20850

Contact: Ms. Lesa Dowtin
Email: lesa.dowtin@fda.hhs.gov
Public Health Advisor
Program Management Office
Office of Device Evaluation
9200 Corporate Boulevard, Room 110N
Rockville, Maryland 20850

Number of Intern Positions: 4-5

Dates of Internship: Year-round

Application Deadline: Flexible - All applicants must submit a completed OF-612, SF-171 or Resume, college transcripts and 3 references. Please include a cover letter summarizing your interests in the medical device area.

Compensation: Unpaid (may receive academic credit)

INTERN PROGRAM

So, you are thinking of spending a semester or summer vacation in the Washington Metropolitan area. You may be about to make one of the best and most exciting decisions of your career if you are considering an internship with ODE. Our Intern Program can be a challenging and rewarding experience for those individuals interested in pursuing careers in the fields of science, engineering and/or medicine. You will be given the opportunity to test your educational interests in a practical work environment, gain entry level professional "real work" experience, work alongside some the Agency's top healthcare authorities, establish professional contacts and most importantly, have a learning experience of a lifetime. Although most interns work for ODE during the summer, we accept a limited number of interns for Fall and Spring semester positions.

MISSION

The Office of Device Evaluation (ODE), Center for Devices and Radiological Health, is a component of the Food and Drug Administration (FDA), a regulatory agency that is responsible for the review of new medical devices to determine their safety and effectiveness prior to their introduction to the marketplace. Examples of medical devices include surgical lasers, breast implants, condoms, artificial joints and prosthetics, invitro diagnostic kits, MRI, lithotripters, artificial heart valves and artificial hearts.

ODE plans, conducts, and coordinates Center actions regarding approval, denial, and withdrawal of approval of Premarket approval applications (PMAs), product development protocols (PDPs), and investigational device exemptions (IDEs); makes substantially equivalent determinations for premarket notification submissions (510(k)’s); and monitors sponsors conformance with requirements of all programs. ODE also coordinates Center classification actvities, reviews petitions for or initiates reclassification of medical devices, provides executive secretariat and other technical support to medical device advisory panels, and conducts continuing review, surveillance, and medical evaluation of the labeling, clinical experience, and required reports submitted by sponsors of approved applications.

DUTIES AND RESPONSIBILITES

The intern will perform all or some of the following duties:

• Obtain and review technical literature or data to determine the safety, efficacy, and degree of risk to the public health of medical devices;
• Perform administrative duties associated with device submissions, write minutes of technical and administrative discussions held between division personnel, industry, and management;
• Assist senior reviewers in obtaining and reviewing technical data and material related to medical device submissions (510(k)s, IDEs, and PMAs);
• Perform literature searches for senior scientists and prepare summaries;
• Assist in preparing correspondence regarding informal inquiries about various types of medical devices.
  

OTHER PROGRAM ACTIVITIES

The ODE Intern Program includes a welcome session with the Office Director, opportunities to participate in public meetings, brown bag lunch semina5rs with key Office officials, and intern get-togethers.

LEGAL REQUIREMENTS

The intern may not have any financial interests whatsoever in any aspect of the commercial device manufacturing/distributing industry, or release, publish, or disclose non-public information, specifically any of the facts involved or obtained while serving as an intern, including confidential commercial information and trade secret matters.

HOUSING

If you do not reside in the Washington Metropolitan area and do not have a friend or relative that can put you up for a while; we have compiled the following list to assist you in your search if you need suitable housing during your stay in Washington:

• Apartment Hunting - obtain copies of the following:
• Apartment Shoppers Guide – (301) 587-1111
• The Washington Post Classified Section

Dormitory Housing

Contact some of the local universities' housing offices to obtain detailed information and to arrange for dormitory housing. Find out when the housing office will be accepting applications, make sure you are near the metro rail service and keep in mind that this option may be a little more expensive than renting an apartment.

Local Universities include:

• American University - (202) 885-2599
• Catholic University of America - (202) 635-5277
• George Washington University - (202) 994-6688
• Georgetown University - (202) 687-3999
• Howard University – (202) 806-6131
• University of Maryland at College Park – (301) 314-2100

Device Evaluation Home

Updated January 17, 2008