Science & Research

CDRH's Experiential Learning Program

The 2019 Spring ELP Proposal Submission Period is open from 02/04/2019 - 03/04/2019 

The 2019 Spring training needs are listed in the Related Resource Section below for interested stakeholders to review during the proposal solicitation period. Please Note, the location to submit your 2019 proposals has been changed to the ELP email address: ELP@fda.hhs.gov. The 2019 Spring ELP Proposal Submissions are due by noon on Monday, March 4, 2019. CDRH will collecting proposals twice each fiscal year, in February and September. Details about the ELP Site Visit Process including how to submit a proposal can be found in the Related Resource section below.

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 proposal following the steps below;

  1. Review the table of Training Needs displaying the identified Areas of Interest in the link below.
  2. Determine which Area of Interest your site would like to provide training for during a visit to your location. Each visit may occur over one or more days.
  3. Utilize 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 in ensuring we are able to quickly match your request with the proper SME.
    • Typically one site visit will address one Area of Interest and can occur over one or more days, which is dependent on content and the agenda proposed by the site. Occasionally, sites will list two 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 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 the ELP Program Manager within the specified submission dates below in order to be considered eligible for that training cycle. When the current period is OPEN, you may send your proposal to this email 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 Manager at ELP Inquiries or (240) 402-2246.

Related Resources

Current Submission Period Status: OPEN
Current Submission Period: 02/04/2019 - 03/04/2019 12:00 pm EST
Email Proposals here: ELP@fda.hhs.gov

Page Last Updated: 02/04/2019
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