The Experiential Learning Program (ELP) is a program designed to help all levels of FDA within the Center for Devices and Radiological Health (CDRH) better understand real-world experience as it relates to the design, manufacture and use of medical devices. The ELP program aims to collaboratively explore device technology and obtain the necessary knowledge to enhance the review process and support communication between sponsors and the CDRH review staff.
MCRA's experts will provide insights and case studies on key strategic considerations in the important areas of technology development as it relates to industry, and the related impact of timing and cost in creating both value and mitigating risk. Additionally, as reimbursement and healthcare economics is becoming increasingly more important, MCRA will address how procedure labeling affects reimbursement coding and how Health Technology Assessment Groups and payers determine the increasing clinical evidence requirements that FDA regulates, which increases the investment required for successful commercialization of both new and existing technology.
Speaking on the impact of programs like ELP, MCRA's General Manager, David Lown said, "MCRA is proud to be selected by FDA to participate in its ELP program. It confirms the value of our experience and the expertise our consultants deliver to over 500 medical device clients globally. Our hope is that FDA benefits from our CRO's shared knowledge in the areas of regulatory affairs, reimbursement, quality assurance and compliance"
For more information on MCRA, please visit www.mcra.com.
About MCRA
Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and medical device industries. MCRA's value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA's integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves over 500 clients globally.
Contact
David W. Lown
General Manager
212.583.0250 ext. 2111
dlown@mcra.com