CHI commends FDA's recognition of more efficient regulatory pathway for innovative medical devices

California Healthcare Institute issued the following response today to the U.S. Food and Drug Administration's (FDA) "Medical Device Innovation Initiative:"

“It is essential that the FDA maintains focus on initiatives that strengthen the medical device review process, bringing greater clarity and consistency, while ensuring the U.S. maintains its competitive edge.”

"CHI commends the FDA for its recognition of the need for a more efficient regulatory pathway for innovative medical devices that have the potential to improve lives," said CHI President and CEO David L. Gollaher, Ph.D. "It is essential that the FDA maintains focus on initiatives that strengthen the medical device review process, bringing greater clarity and consistency, while ensuring the U.S. maintains its competitive edge."

"We look forward to reviewing the FDA's new program in further detail and discussing potential implications on biomedical research and development with the Agency."