A small, focused regulatory consulting firm based in South Florida and Washington DC
Our specialty is preparing, submitting, and shepherding 510(k) Premarket Notifications through the U.S. Food & Drug Administration (FDA). We cater both to individuals and small businesses that create, manufacture, and/or import medical devices for the American market. Although we restrict the number of clients at any one time, over the past decade they have spanned the globe--from North and South America to Europe and Asia. Their regulatory experience is generally limited. So they need someone to guide them step-by-step through FDA's maize of rules and requirements.
John F. Gillespy, MBA
John began his career as a CPA with the international accounting firm, PricewaterhouseCoopers, in Charlotte, NC. He then spent time with two Fortune 50 firms, including a stint on IBM Corp.'s #1 sales team in Orlando, FL, before discovering an enduring passion for small business and entrepreneurship.
His academic credentials include a BA in Economics from Duke University, a BBA in Accounting from Stetson University, and an MBA in Finance and Marketing from Duke's Fuqua School of Business, where he was a Fuqua Scholar.
John's experience in small business began as CFO of a boutique investment banking startup. That led to co-founding a related venture, then to starting a property-management company that he ran for 14 years. The Great Recession led him to work in the dental imaging industry at an inflation-adjusted salary less than his first job out of college. More importantly, one of the skills he learned there enabled him to launch FDA 510k Consultants, LLC, in 2016.
John Gillespy periodically visits 510k reviewers at FDA's massive headquarters complex in Silver Spring, MD
HIs philosophy is to deliver top-shelf service at an affordable price. That is possible by focusing on a niche within regulatory, the 510(k) pathway for new medical devices. John is transforming this niche by putting the customer first--and bringing transparency into the industry's pricing practices.
Photo Left: FDA Headquarters, Silver Spring, MD
Photo Right: US Capitol Building, Washington, DC
“We're good at what we do because that's all we do--clear medical devices for sale in the United States through the complex 510(k) Premarket Notification pathway. Time is money. Why lose months getting new products to market? Hire the team that enjoys helping your company grow. Call or contact us today. The initial consultation is free."
John F. Gillespy, President, FDA 510k Consultants, LLC