Science & Research

CDRH's Experiential Learning Program

Important information about the ELP and the Site visit application process is provided below. Please review all information on this page for details on the program and instructions on how to get involved. Please refer to RELATED RESOURCES at bottom of page for the most current program status and details.

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 members are aware of and understands 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. Furthermore, CDRH assures 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 and Organizational Excellence as strategic priorities, specifically having the perspective of our stakeholders and understanding implementation of these 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 throughout the world. 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. This component is a collaborative effort to enhance communication and facilitate 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 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 encourages applicants to 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 Areas of Interest, sample site visit requests, and a sample site visit agenda below. 

Areas of Interest

In this training program, groups of CDRH staff will observe operations in the areas of research, device development, in making coverage decisions and assessments, incorporating patient information and reimbursement, manufacturing, academia, and health care facilities. The areas of interest for visits include various topics identified by managers at CDRH. These areas of interest will be listed in this website and are intended to be updated quarterly, and assigned a one month submission window timeframe. Any site interested in ELP participation is encouraged to preview the identified Areas of Interest by viewing the list in Related Resources below. Once you have determined an Area of Interest to address in your ELP proposal, please utilize the Sample Site Visit Request and the Sample Site Visit Agenda templates also located in Related Resources at the bottom of this page. Please be sure you have read and understand the submission instructions listed below;

Application Process Summary

Any stakeholders interested in placing a proposal in the program, please view the Submission Period for proposal submission dates as well as the current Submission Period Status as listed below. If Submission Period Status is OPEN, you may submit a proposal to the program by following the steps below;

  1. Review the table of Training Needs displaying our identified Areas of Interest in the link below (this table will NOT be displayed while Submission Period Status is “CLOSED”).
  2. 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.
  3. Utilize the Site Visit Sample Request and the Site Visit Agenda Templates linked 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 in ensuring we are able to quickly match your request with the proper SME.
    • Typically 1 site visit will address 1 Area of Interest and can last 1 or more days, which is dependent on content and the agenda proposed by the site. Occasionally, sites will list 2 or more areas of interest in a proposal and may request to combine them into one site visit, or separate them entirely. However, logistics and resource availability will determine whether or not a site is selected for a visit under the ELP. Please keep this in mind when submitting a proposal containing several areas of interest.
  5. Proposals must be submitted to ELP Program Management within the specified dates below in order to be considered eligible for that relevant training cycle. When the current Period is OPEN, you may email your proposal to this location; ELP Proposal Submissions
  6. Please ensure your proposal(s) are submitted according to the requirements as listed in the submission templates in the links below.
  7. If you have any questions regarding submitting a proposal or any ELP related questions, you may contact ELP Management at ELP Inquiries or (240) 402-2246.

Related Resources

Current Submission Period Status: CLOSED
Next Submission Period: 4th Quarter Dates TBD
Email Proposals here: ELP@fda.hhs.gov

Page Last Updated: 08/04/2017
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