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Kshitij Mohan: 10 People Who Changed the Medtech Industry
Mohan, a former ODE director and former deputy director of CDRH, crafted the basis of FDA's 510(k) program.
June 6, 2013
2 Min Read
Any device successfully approved through FDA's 510(k) program owes a debt to Kshitij Mohan. In 1986, Mohan wrote what would become known as the “Mohan Memo,” a document of policies that formed the basis of subsequent legislation related to FDA's 510(k) premarket notification program.
Mohan started his career at FDA, serving in a variety of roles including heading up science and technology programs, product evaluations, and medical device approvals. During his tenure as director of the Office of Device Evaluation and acting deputy director of CDRH, Mohan cleared the entire backlog of medical device applications by creating polices (including his famous memo) that were later codified into revisions of medical device laws.
After leaving FDA in 1988 Mohan continued in his mission to improve and better serve the device industry and its innovators. In a June 1993 article in the New York Times Mohan, then corporate vice president at Baxter International, criticized FDA's stringent review policies imposed by then-commissioner David Kessler, saying, “The pendulum may swing back eventually, but the pendulum at FDA is more like a wrecking ball . . . To the patient, the impact may be the same if you deny good technology as if you allow bad technology on the market."
In 2000, Mohan joined Boston Scientific, serving as senior vice president and chief technology officer. He led the company's research, development, clinical affairs, regulatory affairs, and government affairs units, as well as its corporate technology centers. He then became the chief regulatory and technology strategist at the Washington, DC, offices of the law firm King & Spalding, where he worked with medical device, biologics, and pharmaceutical firms on product development and FDA approval strategies, and assisted firms with clinical trials, quality systems and regulations, ventures and acquisitions of medical technology firms, and public policy issues.
Mohan retired in 2008 as CEO of Cytomedix Inc., a public biotech company with a proprietary technology for treating nonhealing chronic wounds. He passed away in 2010.
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