Calling all medical device companies, academics, contract manufacturers, incubators, tech accelerators, health insurers, third party test labs, and healthcare facilities! FDA wants to come visit YOU!
[And not to worry, they won't throw in a free "inspection" while they're there.]
The Center for Devices and Radiological Health (CDRH) is offering an innovative learning opportunity for new and experienced FDA review staff. The Experiential Learning Program (ELP) is intended to provide a formal training mechanism for regulatory review staff to visit research, clinical, manufacturing, and healthcare facilities to observe how medical devices are designed, developed, and utilized. The ELP is intended to provide CDRH staff with an opportunity to understand the policies, laboratory and manufacturing practices, and the challenges addressing patient perspective/input, quality system management, and other challenges that impact the device development life cycle.
It's always exciting for FDA reviewers to leave their offices in Silver Spring to go out and see what you're doing! This program is a collaborative effort to enhance communication and facilitate the premarket review process. As mentioned earlier, these visits are not intended for FDA to inspect, assess, judge, or perform a regulatory function (e.g., compliance inspection), but rather, they are an opportunity to provide CDRH review staff a better understanding of the products they review, how they are developed, the voice of the patient, challenges related to quality systems development and management in the product life cycle, and how medical devices fit into the larger healthcare system. And hey, maybe it'll help some people in industry realize that FDA is made up of real flesh-and-blood humans too! We all move forward when we can learn from each other.
Areas of Interest
Areas of Interest for visits are identified by managers at CDRH and are listed on the FDA website (see link below). The Areas of Interest will be updated quarterly, and assigned a one month submission window time-frame. If you're interested in ELP participation, you should preview the identified Areas of Interest by viewing the list. Once an Area of Interest has been determined, the Sample Site Visit Request and the Sample Site Visit Agenda templates can be utilized to make a request for participation. Currently, FDA has listed biocompatibility, combination products, clinical trials/research, device development/manufacturing/demos, digital health/software, innovation/health technology assessment, in vitro diagnostics, standards conformity testing, and quality management systems as Q1's Areas of Interest.
Application Process Summary
Any stakeholders interested in placing a proposal in the program may submit a proposal to the program using following the steps:
- Review the table of Training Needs displaying CDRH identified Areas of Interest.
- Determine which Area of Interest your site would like to provide training for during a visit to your location. Each visit may last 1 or more days.
- Utilize the Site Visit Sample Request and the Site Visit Agenda Templates to fill out your proposal for submission.
- Complete all fields in the Site Visit Sample by first listing the Area of Interest along with its Identifier Code.
- Proposals must be submitted to ELP Program Management within the specified dates (8/24/2018 – 9/26/2018 12:00 pm EST) in order to be considered eligible for that relevant training cycle. Proposal may be emailed to email@example.com.