7/13/2021
Image by Allen_Henderson from Pixabay
A recent US Food and Drug Administration (FDA) warning letter to a device sponsor involves the sponsor marketing a device used for dialysis without an approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE). The device was previously cleared through the 510(k) pathway. However, the sponsor made significant changes to the design and function of the device. The description of the device under the 510(k) is for the healthcare provider to adjust the rate of the fluid removal, but the device in question uses “adaptive feedback” and is automated. This change could impact the safety or effectiveness of the device and increase risk due to the reduction of the healthcare provider’s monitoring and therefore requires FDA clearance or approval. The device sponsor is required to correct the violations or be subject to regulatory action including seizure, injunction, and civil money penalties.
What are your thoughts on the warning letter?
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