scPharmaceuticals, Inc.: Furoscix™ Furosemide

Act for Furoscix™ Furosemide), 80 mg/10 mL, Drug-device combination product.

The Agency believes these alarms are critical to the safe operation of the device.

Provide evidence to support the new mitigations including any additional testing to support design or labeling changes.

5. When revisiting the risk analysis, the Agency has the following comments that need to be addressed for specific aspects of the submission including the risk management, design verification/validation and human factors sections (See Human Factors section, request for updated use-related risk analysis).

IEC 62304. Since we consider the alarm an alarm that could prevent potential death or serious injury, change your classification to Safety Class C. With this change, describe the additional measures you need to take to comply with Safety Class C and provide the evidence.

Software Contained in Medical Devices, issued on May 11, 2005, recommends a SDS document be provided for software with a Major Level of Concern, and the traceability document to trace the SRS to the SDS.

January 11, 2002, recommends SRS and SDS requirements are complete.

Software Contained in Medical Devices, issued on May 11, 2005, recommends unresolved software defects be explain with adequate detail.

January 11, 2002, recommends unit testing is performed per a protocol with adequate description including the code coverage.

25. The Furoscix Infusor Product Design Clinical Validation Study (PDCV), Study CP-00001 did not meet its primary endpoint, "Absence of Major Product Failure.

If the training is performed using a video presentation, the video should be a component of the proposed labeling.

27. The human factors (HF) data do not support a conclusion that your proposed product can be used safely and effectively by the intended users for its intended uses and use environments.

©" However, we disagree because delayed, partial, or omitted treatment may require medical intervention and potential hospitalization.

We recommend that you submit your updated use-related risk analysis and human factors validation study protocol for review prior to commencing the study.

29. We recommend you consider the following as you update your use-related risk analysis and design your HF protocol methodology:

30. Our review of the proposed product's labels, labeling and video identified areas that should be modified.