FDA Specifies When Existing Devices Need New 510(k) Process

A new FDA draft guidance specifies what kinds of changes in existing medical devices would require new 510(k) submissions, according to an FDA release.

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Read the draft guidance.

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