Michael John

Michael John

Vice President, Cardiovascular Regulatory Affairs
Background

Mr. John has more than 20 years of cardiovascular scientific experience. He has provided technical leadership and expert scientific judgment to the review of a wide array of interventional cardiology devices including (but not limited to) fully biodegradable drug-eluting stents, metallic drug-eluting stents, atherectomy devices, angioplasty balloons, robotic percutaneous interventional systems, automated contrast injection systems, and specialty catheters and guidewires.  

In addition to the broad spectrum of standard regulatory decisions involved in the FDA approval process, Mr. John oversaw the review of multiple complex De Novo Applications, Breakthrough Device Designations, Early Feasibility Study IDEs, and Original PMAs.  Mr. John served as a focal point for industry representatives and cardiovascular thought leaders in the cardiovascular arena, and has represented FDA at numerous scientific conferences and symposia.
 

Education

Mr. John received his Bachelor of Arts degree in Philosophy from the University of Virginia, and his Master of Public Health in Epidemiology and Biostatistics from the George Washington University.

Experience

Prior to joining MCRA in 2019, Mr. John served as Chief of the Interventional Cardiology Devices Branch in the Division of Cardiovascular Devices at the US Food and Drug Administration.  As Branch Chief, Mr. John reviewed and edited scientific memoranda from a multi-disciplinary team of scientists and health care professionals, with branch-level signatory authority over all regulatory decisions on PMA, IDE, and 510(k) medical device submissions pertaining to coronary interventional products.  Many of the devices that were under Mr. John’s regulatory purview are essential tools in the fight against heart disease, the leading cause of death in the United States. 

Prior to becoming Branch Chief, Mr. John was an Animal Testing Reviewer and Lead Reviewer in the Division of Cardiovascular Devices.  Mr. John lent his technical expertise to the review of devices in each of the existing branches of the Division, including drug-eluting stents, transcatheter heart valves, ventricular assist devices, cardiac ablation devices, pacemakers, defibrillators, leads, annuloplasty rings, extracorporeal oxygenators, left atrial appendage and septal defect occluders, and renal denervation devices.    

Prior to joining FDA Mr. John conducted cardiovascular research at The Massachusetts General Hospital in Boston, MA under Aloke Finn, MD and Herman “Chip” Gold, and at the Armed Forces Institute of Pathology (now CVPath Institute Inc., of Gaithersburg, MD) under the direction of renowned cardiovascular pathologist Renu Virmani, MD, where he specialized in cardiovascular pathology and histology, and performed countless stent implantation procedures in animal models.

Mr. John manages and directs the MCRA Cardiovascular Regulatory Affairs department.  Mr. John leads the firm’s submission process and global regulatory strategy for MCRA, which encompasses all aspects of the FDA approval process from non-clinical testing to clinical trial design and submission of the marketing application.    

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