This article provides advice on how to manage design changes throughout the regulatory submission process for a 510(k) submission.
Your design control procedure defines the process for controlling design changes, but how to do you control design changes in relation to your 510(k) submission process?
Design Changes Before You Submit a 510(k) Submission
Design teams are always implementing design changes to devices, and often these changes occur just before you intended to submit a 510(k) due to feature creep or project delays. The FDA explains the process of controlling changes during the design process in the 1997 Design Control Guidance Document. The guidance also explains that making design changes later in the process can be expensive, because verification and validation testing may need to be repeated due to the impact of a design change. Therefore, make sure you identify all your potential hazards early in the design process and evaluate the risks before you finalize your design outputs. The FDA will allow you to make as many changes as you like during the design process, but changes after you finalize your design outputs will result in 510(k) project delays and increase verification and validation costs.
Design Changes During a Pending 510(k) Submission
If you want to incorporate a new indication, new technology or some other type of design change to your device, while your 510(k) submission is pending, the FDA will require you to submit a new 510(k) and the associated fee in accordance with the user fee and refunds guidance document. This is explained in frequently asked question # 10 of the referenced guidance document. If the design change is important to implement as soon as possible, you have two choices:
- Wait until the pending 510(k) submission is cleared, and then submit a new 510(k) for the design changes. If the change is minor, you may be able to submit a Special 510(k) and receive the second 510(k) within 30 days of the first 510(k).
- Withdraw your first 510(k) submission, and submit a new 510(k) with the design change.
Be careful with option # 2. It may take you a while to prepare the second submission. If the FDA refused to accept your first 510(k) during the RTA screening process, you have the choice of requesting a refund or submitting missing information. If the FDA requests additional information after your submission has been accepted, you may be able to obtain a refund if you are unable to provide the additional information within 180 days. Therefore, prepare your second 510(k) and then make a decision if you should withdraw the first submission or wait a little longer.
Design Changes After 510(k) Clearance
When you receive 510(k) clearance, you will eventually make a change to your device by choice or by necessity. When you make this change, you must determine if a new 510(k) is required. The FDA published a new draft guidance document on August 8, 2016 to help you determine when to submit a new 510(k) for device modifications. The guidance document has five different flow charts:
- Main Flow Chart
- Flow Chart A for Labeling Design Changes
- Flow Chart B for Technology, Engineering and Performance Design Changes
- Flow Chart C for Materials Design Changes
- Flow Chart D for IVD Design Changes
This guidance document also provides detailed examples of how to document the rationale for why design changes do not require a new 510(k) submission. The guidance also explains when a catch-up 510(k) may be required for a series of sequential design changes–each of which did not require a new 510(k) submission.
The best approach to managing design changes is to take a risk-based approach to design controls. If you would like to learn how to combine product risk management with design controls, you might be interested in Medical Device Academy’s webinar on the topic. If you have questions about your next 510(k) submission, click on the button to schedule a 15 minute meeting.
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