There are two things going one here and, while related, you need to consider them separately.
In the first case, something happened that cause the residual risk to be unacceptable, so you initiated a correction which FDA classified as a recall. This brings the device residual risk back to the design level.
In the second case, you want to make design changes to reduce the residual risk and to improve reliability.
The question is, as I understand it, whether you need to file a 510(k) to cover the design improvements.
To answer the question, start with the FDA guidance documents on when to submit a 510(k).
The non-software document says, "If a manufacturer modifies their device with the intent to significantly affect the safety or effectiveness of the device (for example, to significantly improve clinical outcomes, to mitigate a known risk, in response to adverse events, etc.), submission of a new 510(k) is likely required".
From your question it sounds as if you do have the intent to significantly affect the safety of the device, so an 510(k) is in order. Two points here. The guidance document takes the point of view that an improvement is a significant change and requires a 510(k). It also uses "mitigate a known risk" which is the wrong term. It should have been "reduce a known risk".
The next issue to consider is, "This guidance is also intended to apply to situations when a legally marketed existing device is the subject of a recall, correction, or removal, and a change in the device or its labeling is necessary. For more information on recommended procedures in a recall situation, please see Blue Book Memorandum K95-1, 510(k) Requirements During Firm-Initiated Recalls (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm 080297.htm). As stated in that guidance, if a correction alters a device rather than simply restoring it to its original specifications, submission of a new 510(k) may be required."
It sounds like you do not need to make a change to the device to restore the initial residual risk profile. However, read K-95 to determine whether it applies.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 09-Dec-2022 06:19
From: Anonymous Member
Subject: When FDA recall of medical device triggers a 510(k)
This message was posted by a user wishing to remain anonymous
Hi all,
Would like to hear your thoughts and insights on when a FDA recall of medical device would trigger a 510(k) notification.
We have initiated a class II recall in USA in which a correction to the device was made to bring back the residual risk to an acceptable level.
Going forward, design changes are proposed to further decrease the risk as low as reasonably practicable (ALARP) without affecting however the risk profile for the device and to further improve device reliability.
Would you consider a 510(k) submission is required to bring forward the design changes but also to inform FDA that risk profile was changed and brought back to acceptable level via the recall actions? Or would it be considered that FDA would review such corrective actions and design changes via the Recall department?
Many thanks!