About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.
  • If a manufacturer modifies their device with the intent to significantly affect the safety or effectiveness of the device,submission of a new 510(k) is required. Changes that are not intended to significantly affect the safety or effectiveness of a device, should also be evaluated to determine whether the change could significantly affect device safety or effectiveness.
  • The manufacturer should first conduct a risk-based assessment of whether the change could significantly affect the device’s safety or effectiveness, either positively or negatively. This risk-based assessment should identify and analyze all new risks and changes in existing risks resulting from the device change, and lead to an initial decision whether submission of a new 510(k) is required.
  • After a manufacturer considers whether the change was made with the intent to significantly affect safety or effectiveness, the manufacturer should also consider whether the change could have unintended consequences. For example, changes in sterilization may unintentionally affect device materials, or changes to materials may unintentionally affect the performance of the device.
  • A risk-based assessment as referred to throughout this document is based on the combination of multiple risk concepts that are important for managing the risks of medical devices. Hazards and hazardous situations, risk estimation, risk acceptability, risk control, risk/benefit analysis and overall risk evaluation are all concepts that can be applied during the design and development of a medical device. A device change could be considered to significantly modify an existing risk if it changes the risk score, risk acceptability category, or duration of risk.
  • If the initial decision following the risk-based assessment is that submission of a new 510(k) is not required, this decision should be confirmed by successful, routine verification and validation activities. If routine verification and validation activities produce any unexpected results, any prior decision that submission of a new 510(k) is not required should be reconsidered. Note that verification and validation requirements apply for all devices and must be conducted regardless of whether submission of a new 510(k) is required.
  • Evaluate simultaneous changes to determine whether submission of a new 510(k) is required. Because many simultaneous changes may be considered at once, each change should be assessed separately, as well as in aggregate.
  • In using this guidance to help determine whether a particular change requires submission of a new 510(k), manufacturers should conduct a risk-based assessment that compares the changed device to their device as previously found to be substantially equivalent in their most recently cleared 510(k), to their preamendments device, or to their device that was granted marketing authorization via the De Novo classification process. Manufacturers may make a number of changes without having to submit anew 510(k), but each time they make a change, the modified device should be compared to the original device. When the cumulative effect of individual changes triggers the regulatory threshold for submission, the manufacturer should submit a new 510(k). When it does not, the manufacturer must document the change(s).
  • Whenever manufacturers change their device, they must take certain actions to comply with the QS regulation, unless the device in question is exempt by regulation from the QS regulation. The QS regulation requires, among other things, that device changes be documented.
  • When a new 510(k) is submitted for a device with multiple changes, that 510(k) should describe all changes that trigger the requirement for submission of a new 510(k). To help ensure that FDA has a complete understanding of the device under review, that 510(k) should also describe other changes since the most recently cleared 510(k). If a manufacturer makes multiple changes to a device, but only one change triggers the requirement for submission of a new 510(k), the changes that do not require submission of a new 510(k) may be immediately implemented, so long as those changes can be implemented independently of changes that do require submission of a new 510(k). Any immediately implemented change should still be documented in accordance with applicable QS regulations and the manufacturer’s documentation procedures. Those changes should, however, also be described in the new 510(k) for the change that does require submission.
  • Manufacturers should understand that, even though they may follow this guidance and submit a new 510(k), a substantially equivalent determination is not assured.

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