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Wednesday, 02/27/2019 6:42:30 AM

Wednesday, February 27, 2019 6:42:30 AM

Post# of 329444
Hmm! IMO, the FDA can bleed a fledgling startup dry just by delaying approval. Also, IMO, they can accomplish this especially if that startup thinks that FDA clearance is essential for their commercial/economic survival(does that ring a bell?). To bring home the point review the text below:

A Stanford study: What is the average cost to research and develop a medical device?

"It is expensive to bring a medical device to market. A 2010 Stanford study identified the average cost to bring a 510(k) product from concept to market at $31 million. Greater than 77 percent of the cost—approximately $24 million—was consumed on regulatory and FDA-related activities. Sep 1, 2017"


Wow!!
GLTA!!!