The federal agency’s recommendations are part of its efforts to streamline the 510(k) review process in exchange for doubling fees companies must pay to submit applications. The proposed checklist would ensure applications include several elements, such as table of contents or page numbers, and save the FDA’s time spent on crafting letters requesting the missing information.
More Articles on Orthopedic Devices:
Novation Announces Agreement for Orthopedic Standardization Program
Greatbatch Orthopedic Business Slows, Revenue Drops 13%
Intuitive Surgical Reports 2Q Revenue of $537M, Up 26%
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
