Devices & Diagnostics

FDA 510(k) reaction: The trade group (Ohio)

BioOhio is a state-funded non-profit organization that represents and supports bioscience industry, research and education in Ohio. Scott Osborne, BioOhio’s director of business development, said this to say about today’s proposed changes to the U.S. Food and Drug Administration’s 510(k) program.

BioOhio is a state-funded non-profit organization that represents and supports bioscience industry, research and education in Ohio. The state is home to 325 medical device and equipment manufacturers, and at least twice that number of Ohio companies are involved in taking medical devices and equipment to market.

Scott Osborne, BioOhio’s director of business development, said this about today’s proposed changes to the U.S. Food and Drug Administration’s 510(k) program:

“The FDA’s announcement about a new and improved 510(k) review process appears to be on track for new degrees of consistency and predictability. Unquestionably, the most common complaint we hear from BioOhio members about the 510(k) clearance process relates to inconsistency and unpredictability.

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“My 30 years in the medical device industry validate this as a chronic concern of medical device companies. If this becomes the new reality at the FDA, manufacturers will be able to plan their product development timelines and budgets with greater accuracy. And that should make investors happy, too.”