The document is an update to a 1997 guidance document and intends to clarify when device manufacturers should submit pre-market notification for an update or modification to device that has already been approved by the FDA.
Related Articles on the FDA:
FDA Launches Website on Safe Disposal of Used Needles and Other “Sharps”
FDA Approves Anti-Clotting Drug Xarelto
FDA Reports Increase in New Drug Approvals in FY 2011
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
