The ODE Site Visit Program is an ODE-sponsored educational activity for medical device reviewers to visit manufacturing firms, hospitals, and clinics to observe the design and manufacturing process, or application, of the medical devices they review. Reviewers have the opportunity to query the manufacturers' scientists and engineers about the manufacturing and maintenance of the medical equipment, or hospital personnel about its application, thus providing the reviewers with useful information about the device and first-hand observation of its development and use.
The Site Visit Program provides educational benefits to FDA reviewers and increases communication among the medical device regulatory, manufacturing, and medical communities.
The ODE Site Visit Program was developed in 1993. Since that time, many CDRH employees have visited firms and/or hospitals to view the development or application of devices such as:
- heart valves
- orthopedic implants
- stents and catheters
- lens care products
- breast implants
- surgical drapes, gowns and gloves
- innovative surface modifications
- implantable middle-ear hearing devices
- IV pumps and ports
- tissue/surgical sealants
- knee resurfacing
Each year, after receiving input from the review staff regarding technologies they would like to explore more thoroughly, the ODE Program Management Office solicits interest from manufacturing firms, hospitals, and clinics to host the site visits. Time and budget restraints limit the number of site visits per year.
How to Participate in the Site Visit Program
You may contact the ODE Program Management Office to express your interest in hosting a site visit. Your participation is not guaranteed but it will ensure that your company receives due consideration. The email address for the ODE Site Visit Program Coordinator is Debra.Grygier@FDA.HHS.GOV.