scPharmaceuticals Services, Inc: Furoscix™ “

Federal Food, Drug, and Cosmetic Act for Furoscix™ "(Furosemide), 80 mg/10 mL, Drug-device combination product.

It is our expectation that you submit your tobe-marketed device and all finalized documentation to support your device functions safely and effectively when responding to a Complete Response or submitting a new application.

We recommend: a) you work with MAF Holder to ensure adequate resolution of the identified deficiencies, and b) resubmit your NDA only once the deficiencies are all resolved and adequate documentation is present in the MAF.

5.2.1.1.f of IEC 60601-1-2:2014, please revise this warning to "WARNING:

2014 (https://www.fda.gov/media/84830/download) h. Infusion Pumps Total Product Life Cycle from December 2014 (https://www.fda.gov/media/78369/download)

Please provide the originally requested labeling updates sent on July 22, 2020 and ensure your labeling matches your proposed use-case.

However, we note that your human factors/usability use-related risk analysis does not assess the risk of a patient applying the infusor if they have the characteristics listed in items 1 through 6 above.

However, your Device Improvement Report submitted on September 29, 2020 indicates that your proposed device was modified subsequent to the HF study.

We recommend you update your comprehensive use-related risk analysis taking into consideration the device modifications.

Based on the aforementioned information and data, you should determine whether you need to submit the results of another human factors (HF) validation study conducted under simulated use conditions with representative users performing necessary tasks to demonstrate safe and effective use of the product.

We recommend you submit your study protocol for eedback from the Agency before commencing your study.

Satisfactory resolution of these deficiencies is required before this application may be approved.

Comments about Facility Inspection Not Completed Due to Travel Restrictions:

You may respond to deficiencies in this Complete Response Letter while the travel restrictions remain in effect.

However, even if these deficiencies are addressed, the application cannot be approved until the required FDA inspection is conducted and any findings are assessed.

We have provided comments below and recommend that you implement them prior to resubmission of this NDA.

August 22, 2019 and agree with your proposal.