WASHINGTON, July 26, 2017 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization to the medical device industry, today announced that it has authored a new white paper, “The Potential FDA Impact of the 2018 Presidential Budget Request”. Following the release of the 2018 budget request, MCRA looked to analyze the potential impact of funding the Food and Drug Administration (FDA) Medical Device Review Program exclusively through user fees.
As the medical device market grows due to continued innovation and changing demographics, it is imperative for industry to be able to successfully commercialize their technologies and procedures within a reasonable and definable time frame. Since its latest iteration in 2012, the Medical Device User Fee Program has helped speed up decision times. With the new proposed budget request, uncertainty is a challenge companies will have to overcome. MCRA looks to define and clarify some of that uncertainty with this white paper.
The white paper is the result of the collaboration between Vice Presidents Glenn Stiegman and Tim Hunter, Senior Director Keith Tode, and Associate Jack Kiraly. Mr. Kiraly, a recent addition to the MCRA team, had this to say: “We are concerned by the proposed budget, however, even if passed, there will still be opportunities for industry to navigate regulatory pathways to approval.” MCRA has the experience of former FDA professionals, as well as an integrated team of regulatory, clinical, quality, reimbursement, and healthcare compliance specialists.
Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. 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 nearly 500 clients globally.
David W. Lown
212.583.0250 ext. 2111
SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC