Todd Courtney, M.S., CQIA
Prior to joining MCRA, Mr. Courtney spent 15 years at the FDA. He most recently served as the Assistant Director of the Anesthesia Devices Team for over 8 years, where he managed a team of engineers, clinicians, and compliance officers in the total product lifecycle review of clinical, scientific, and other supporting dat for anesthesia medical device regulatory submissions, including, but not limited to, Breakthrough, STeP, 510(k), IDE, PMA, de novo, SaMD, CDSS, and PEUAs. He also oversaw the review of combination product devices within the anesthesia device team, including certified medical gases and drugs delivered by CDRH-led devices. Additionally, he managed the reviews of recall classifications, warning letter drafts and responses, complaints, and other compliance actions.
During this time as Assistant Director for Anesthesia, Mr. Courtney was also chosen as one of the first FDA Fellows at Fogarty Innovation (formerly known as Fogarty Institute for Innovation). In that role, he met with small start-up companies to discuss their regulatory challenges developing nascent technology and provided regulatory insight and strategies to help them navigate the regulatory landscape.
Mr. Courtney holds a Bachelor of Science degree in Civil Engineering from the University of New Orleans. He also received a Master of Science degree from the University of Memphis in Biomedical Engineering, with a focus on gait analysis, and a Master of Science degree in Bioengineering from the University of Pittsburgh, with a focus on tissue engineering of electrospun scaffolds.
Prior to his time as Assistant Director for Anesthesia at the FDA, Mr. Courtney served as Acting Branch Chief for the Circulatory Support Devices Branch, in which he provided guidance and leadership to the branch in the review of medical devices and managed the branch through both a 515(i) reclassification panel and Pediatric Advisory Committee Meeting.
Mr. Courtney began his career at the Agency as lead reviewer for 7 years in the Peripheral Vascular Devices Branch and Peripheral Interventional Devices Branch, in which he was responsible for the review of balloon angioplasty catheters, atherectomy and thrombectomy devices, chronic total occlusion systems, and renal denervation devices, as well as many other device types.
During his time at the Agency, he also served on many working groups, including the 510(k) Modernization working group and the Tools and Template quality system committee. Mr. Courtney also developed the PDF version of the Refuse-to-Accept checklists for 510(k) submissions.
Overview
As Vice President, Anesthesia, Respiratory, & Sleep Regulatory Affairs, Mr. Courtney works closely with MCRA's Regulatory department to support medical device clients as they work to develop submissions to FDA at every stage, including through the total product life cycle. This includes the development of regulatory strategies, as well as performance testing, pre-clinical and clinical testing protocols, and the appropriate documentation intended to support market authorization.