The Center for Devices and Radiological Health (CDRH) offers an innovative learning opportunity for new and experienced 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.

Background

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. CDRH has identified Partnering with Patients and Promoting a Culture of Quality, Simplicity and Collaboration, and Organizational Excellence as priorities. Specifically, gaining the perspective of our stakeholders and understanding implementation of how these principles are applied within their institutions would provide great insight to FDA review staff. The Center encourages applicants to consider including opportunities to discuss patient perspective and meeting the challenges of quality systems design and management as they contribute to the success of the device development lifecycle.

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 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 concerns that impact the device development life cycle. This program is a collaborative effort to enhance communication and enhance facilitation of the premarket review process. The Center 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 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 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 other FDA site visit programs.

CDRH recommends applicants consider including opportunities to discuss how Patient Perspective and Effective Quality Systems Management contribute to the success of the device development lifecycle. 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

In this training program, groups of CDRH staff will 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 below. When you have determined a Training Area of Interest to submit in your ELP proposal, please use the Sample Site Visit Request and the Sample Site Visit Agenda templates located in Related Resources at the bottom of this page.

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. If the submission Period is OPEN you can submit a Site Visit Proposal following the steps below;

1. Review the table of Training Needs identified by Areas of Interest in the link below.
2. Determine which Area of Interest your site would like to provide training for. Select only an Area of Interest. Visits may occur over one or more days.
3. Use the Site Visit Sample Request and the Site Visit Agenda templates links below to fill out your proposal for submission.
4. 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 proper 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 to two days is most common but is dependent on content proposed by the site.
   • Logistics and resource availability will determine whether a site is selected.
5. Proposals must be submitted to the ELP Program Manager when the submission period is OPEN. Send your proposal to this email ELP Proposal Submissions.
6. Please ensure your proposal is submitted according to the requirements listed in the Site Visit Sample template below.
7. If you have any questions regarding submitting a proposal or any ELP related questions, you may contact ELP Manager at ELP Inquiries or (240) 402-2246.

Related Resources

Current Submission Period Status: CLOSED
Next Anticipated Submission Period: July 2020
Email Inquiries here: ELP@fda.hhs.gov

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