According to FDA’s regulation, a premarket notification must be submitted to FDA when there is

(a) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.

(b) A major change or modification in the intended use of the device.

Any guidance on 510(k)s for changes to a legally marketed device should consider the role the Quality System (QS) regulation plays in changes to devices. For some types of changes to a device, the FDA believes that submission of a new 510(k) is not required and that reliance on existing QS requirements is the least burdensome approach to reasonably assure the safety and effectiveness of the changed device.Regardless of whether a change requires premarket review, the QS regulation requires manufacturers of finished medical devices to review and approve changes to device design and production and document changes and approvals in the device master record. Any process whose results cannot be fully verified by subsequent inspection and testing must be validated, and changes to the process require review, evaluation, and revalidation of the process where appropriate