FDA Clarifies When Device Modifications Require New 510(k)s
New 510(k) submissions.
The new guidance, 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device, is part of the agency’s Plan of Action for Implementation of 510(k) and Science Recommendations rolled out in early 2011, replaces the guidance document Deciding When to Submit a 510(k) for a Change to an Existing Device issued in 1997.
Device changes or modifications that “could significantly affect” the product’s safety or effectiveness typically require new premarket notification submissions from manufacturers, according to the new guidance document. The FDA identifies manufacturing changes, labeling changes, technology or performance specification changes, and material changes as types of modifications typically requiring new 510(k) submissions, and provides questions manufacturers should use to determine whether any such changes made to their devices have significantly affected their products’ safety or effectiveness.
In instances where a manufacturer determines that device changes warrant a new 510(k) submission to the FDA, the firm should include all planned changes along with a comparison of those planned changes to the device’s characteristics described in its previous 510(k) submission. Along with changes that affect device safety and effectiveness, the manufacturer should also identify any and all other planned changes to its product in the new submission.
In cases where the manufacturer determines that planned device modifications do not impact safety or effectiveness—and thus do not require a new 510(k) submission—the firm should document the basis for that conclusion as well as scientific justification for deciding that planned changes will not affect safety or effectiveness, and maintain that documentation in order to satisfy Quality System regulatory requirements.
The guidance document does not provide criteria specific to nanotechnology; instead, the FDA recommends that manufacturers whose devices incorporate nanomaterials consult with the regulator in order to determine whether device changes require new 510(k) submissions. Additional guidance targeting nanotechnology issues is also planned.