FDA’s device center hopes the effort, which is intended to model a quicker-turnaround “Silicon Valley” approach to system development, will help reduce time-to-market for new devices, and simplify some post-market surveillance efforts.
CDRH says it is taking rapid steps to upgrade its IT and social networking capabilities to deepen its collaboration with device makers and improve communication with the public.
FDA’s device center hopes the project, which is intended to model a quicker-turnaround “Silicon Valley”-approach to system development, will ultimately...
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During the MDIC Excellence in Quality Summit, an expert in product recalls offered several unconventional and somewhat controversial factors that impact how quickly device makers initiate a recall once they discover a problem.
But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.
Record Mako installations in the third quarter fueled growth across Stryker’s orthopedics portfolio, supporting higher revenue in the “Ortho Other” category. Executives said new product launches and software upgrades are broadening clinical applications.
