2024 Fall CDRH ELP Proposal Submission Period is Now Open Through September 5, 2023

August 7, 2023By Véronique Li, Senior Medical Device Regulation Expert

The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP). Through ELP, CDRH staff visit sites that provide formal training and enhance understanding on topics such as how products are developed and how they fit into the larger healthcare system. Site visits can also provide the opportunity to engage with patients on various topics, such as prototyping, trial design and conduct, and product launch and understand the challenges related to quality systems development and management in the product life cycle.

The visits are intended purely to provide a training perspective, and not for CDRH staff to opine on any regulatory functions.

Participation is encouraged from:

  • Companies
  • Academia
  • Clinical facilities
  • Medical device incubators and accelerators
  • Health insurers
  • Health technology assessment groups
  • Others, including previous participants in the ELP or the FDA’s other site visit programs.

One noticeable difference from years past is the option for virtual site visits. These allow CDRH to participate during times when the ability to travel is limited while expanding participation from CDRH staff.

Those interested in submitting a proposal to host CDRH staff should:

1.  Complete a Site Visit Request (Sample Site Visit Request).

a.  Ensure that proposals have only one Training Area of Interest.

b.  Include the Identifier Code with the Area of Interest.

2.  Complete a Site Visit Agenda (Sample Site Visit Agenda).

a.  Identify the site visit duration. (Most common are one- or two-day site visits.)

b.  Indicate ability to host a virtual site visit.

3.  Submit proposal documents by email to ELP Proposal Submissions by September 5, 2023 at 12 PM ET.

ELP Proposals will be selected based on a variety of factors such as applicable areas of interest, CDRH resource availability, and logistical considerations.

As a former participant, it was beneficial to me to engage with companies in person at their place of business and see the equipment used in manufacturing the medical devices that are reviewed by FDA. It was also helpful to hear first-hand the practical challenges companies navigate in bringing products to market. Companies may want to consider submitting a proposal so they can meet the CDRH staff who will be working with them on the review of their regulatory submissions. On the other hand, companies may not want to participate if they are not prepared to host FDA and answer questions, or do not meet one of the areas of interest identified on FDA’s webpage.

Categories: Medical Devices