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Read the draft guidance.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
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