Program Background

The Center for Devices and Radiological Health (CDRH) offers an innovative learning opportunity for new and experienced CDRH review staff. The Experiential Learning Program (ELP) is a collaborative approach to closing the knowledge gap between emerging and innovative technology and the pre-market review of the resulting medical devices.  Because technology continuously evolves, it is essential that CDRH review staff are aware of and understand how medical devices are developed, clinically tested, manufactured, and used.

CDRH is committed to advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and helping to ensure consumer confidence in medical devices marketed in the United States and world-wide.  The ELP is intended to support 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 concerns that impact the device development life cycle.  This program is a collaborative effort to enhance communication and facilitation of the premarket review process.  CDRH is committed to understanding current industry practices, innovative technologies, regulatory impacts and needs, and how patient perspective and quality systems management advances the development and evaluation of innovative devices and monitor the performance of marketed devices.

These formal training visits are not intended for the FDA to inspect, assess, judge, or perform a regulatory function (for example, compliance inspections), but rather, they are an opportunity to provide CDRH review staff with 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.  CDRH encourages participation from companies, academia, and clinical facilities, medical device incubators and accelerators, health insurers, health technology assessment groups, and others, including those that have previously participated in the ELP or the FDA’s other site visit programs.

Applicants can find more information on specific Training Areas of Interest, sample site visit requests, and a sample site visit Agenda in the Related Resources section below.

Training Areas of Interest

The ELP provides groups of CDRH staff with opportunities to observe operations in the areas of research, device development, insurance coverage decision-making processes and assessments, incorporating patient information and reimbursement, manufacturing, academia, and health care facilities.  The Training Areas of Interest reflect topics identified by CDRH managers and are listed on the website twice a year during the two Fiscal Year ELP Training Solicitation Periods.  Sites interested in ELP participation are encouraged to preview the identified Training Areas of Interest listed in the Related Resources section located at the bottom of this page. Once a Training Area of Interest has been determined, please refer to the Sample Site Visit Request and the Sample Site Visit Agenda templates, also located in Related Resources section.

Patient Engagement

Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning and effective collaborations. CDRH is responsible for helping to ensure the safety and effectiveness of medical devices marketed in the United States as well as assuring that patients and providers have timely and continued access to high-quality, safe, and effective medical devices and as such continues to include patient engagement in its 2022-2025 Strategic Priorities.

Gaining the perspective of our stakeholders and understanding implementation of how these principles are applied within their institutions will provide great insight to the FDA’s review staff.  Specifically, CDRH is interested in learning how medical device innovators, developers, manufacturers, distributors, investigators, and others incorporate patient input into a phase or phases of a device’s life cycle.  These may include discovery and ideation, invention and prototyping, pre-clinical testing, pre-market clinical testing (for example, trial design and conduct), product launch, and post-market activities (for example, post-market study design, labeling, and recalls).

CDRH encourages applicants to consider including opportunities to discuss patient perspective for proposal submissions. If you are interested in submitting a proposal for any Areas of Interest stated in the Areas of Interest Table, please also consider including Patient Engagement as a potential supplemental topic. You may do this by checking the Patient Engagement Relevant box in the Sample Site Visit Request document linked at the bottom of this webpage.

Site Visit Format(s)

The Experiential Learning Program is now incorporating virtual site visits into the program. Virtual site visits allow CDRH to continue participation in the program during periods of limited travel. It will also provide greater flexibility in selecting staff for site visits, selecting proposals, and increasing exposure to the program. CDRH is requesting sites indicate their willingness to participate in the Program through virtual site visits.  Please indicate your ability to host a site visit virtually by checking the applicable box in the Sample Site Visit Request.

Application Process Summary

Stakeholders interested in submitting a training proposal should confirm the Submission Period is OPEN and that their proposal supports the current CDRH training topics of interest, then follow the steps below:

Review the table containing the Areas of Interest in the Related Resources section below.

1. Identify the Area of Interest for which your site would like to provide training. Please select only one.  Note: Site visits may occur over one or more days. CDRH is only soliciting proposals for virtual site visits.
2. Use the Site Visit Sample Request and the Site Visit Agenda templates links provided in the Related Resources section below to complete your proposal.
3. Please complete all fields in the Site Visit Sample by first listing the Area of Interest along with its Identifier Code. These two fields are important to ensure we match your request with the relevant CDRH Subject Matter Expert.
   • Your proposal should only contain one Area of Interest.
   • Your proposed agenda may be one single day or can occur over multiple days. One- or two-day site visits are most common, but the site visit duration will be determined by the site.
   • CDRH logistics and resource availability determine whether a proposal is selected.
4. Proposals must be submitted by email to ELP Proposal Submissions.
5. Please ensure your proposal is submitted according to the requirements listed in the Site Visit Sample template.

If you have any questions, you may contact ELP Inquiries or (240) 402-2246.

Related Resources

Current Submission Period Status: OPEN
Current Submission Period: August 4, 2022, at 9am EST – September 6, 2022, at 12pm EST
Email Inquiries here: [email protected]

• Sample Site Visit Request
• Example of Site Visit Agenda
• Site Visit Do's and Don'ts

2023 Fall Areas of Interest (PDF 260KB)