For example, changes in device features, such as labeling, manufacturing and materials, may require new 510(k) submissions.
The document, “Deciding When to Submit a 510(k) for a Change to an Existing 510(k),” replaces a 1997 guidance of the same name.
Read the FDA release on changes in devices that require 510(k) submissions.
Read the draft guidance.
Related Articles on the FDA Device Approval Process:
Journal Editors Blast Studies Used by Critics of FDA Device Process
House Committee Chair Accuses FDA of Overregulating Devices
Devicemakers Ask Congress to Ease Regulatory Burdens on Industry
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.
