FDA Picks MCRA to Train Staff
Walter Eisner • Fri, September 22nd, 2017
The FDA wants its staff to get smarter about reviewing medical devices.
To do that, the agency developed the Experiential Learning Program (ELP) to bring in device experts to train the FDA staff.
On September 13, 2017, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced the FDA has chosen the consultants to lead three training sessions with agency staffers in the areas of clinical trials, reimbursement, and innovation.
Experiential Learning Program
The Experiential Learning Program (ELP) is a program designed to help FDA staff 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 experts, according to the company, 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."
The agency says these formal training visits are not intended for the agency 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.
MCRA's General Manager David Lown said the assignment, "confirms the value of our experience and the expertise our consultants deliver to over 500 medical device clients globally."
Founded in 2004, MCRA serves the neuro-musculoskeletal and medical device industries with expertise in regulatory, reimbursement, clinical research, healthcare compliance and quality assurance areas. The company has offices in Washington, DC, Manchester, Connecticut and New York, New York.
To learn more about ELP, click here.