CDRH Seeks Medical Device Sites for Review Staff Education

By MedTech Intelligence Staff
August 9, 2022


• Categories: 05-Quality/Regulatory, Regulatory

To help reviewers keep pace with rapid advances in medical devices and technologies, the FDA’s Center for Devices and Radiological Health (CDRH) developed the Experiential Learning Program (ELP). ELP provides CDRH review staff with an opportunity to visit sites and gain a better understanding of the products they review.

CDRH is soliciting proposals for 2023 site visits (on-site or virtual) and encourages the submission of proposals addressing Patient Engagement as a supplemental topic. Companies that would like to take part in ELP can apply as part of the 2023 ELP Site Visit Proposal period, which is open now until September 6, 2022 at 12pm EST.

The ELP Program:

• Provides CDRH review staff with opportunities to better understand current industry policies, innovative technologies, laboratory practices, how patient input affects medical device development and quality systems management
• Is a collaborative effort to close the knowledge gap between emerging and innovative technology and the pre-market review of the resulting medical devices

The CDRH notes that these visits are not intended for the FDA to inspect, assess, judge or perform a regulatory function, 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.

Information on the application process is available here.