FDA CRL - scPharmaceuticals Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to scPharmaceuticals Services, Inc. for their New Drug Application (NDA 209988) concerning Furoscix

(Furosemide), an 80 mg/10 mL drug-device combination product. This action followed the company's June 30, 2020, resubmission. The FDA determined the application could not be approved due to several critical issues related to the device component and labeling, under the regulatory framework of Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

Key violations included significant, uncommunicated design changes to the device during the review cycle, which raised concerns about safety and efficacy. The agency also identified outstanding deficiencies in the Master Access File supporting the device constituent and noted issues with biocompatibility testing, particularly regarding differences between test articles and the final product, and inadequate particulate matter analysis. Chemical characterization of leachables lacked clarity on clinically relevant testing conditions and methods for detecting specific compounds. Furthermore, the product labeling was deemed insufficient, failing to provide adequate electrical safety and electromagnetic compatibility (EMC) information as per IEC 60601-1 series, and did not incorporate previously requested warnings on various hazards and essential performance information.

Required actions include submitting the finalized, to-be-marketed device design with comprehensive supporting documentation, resolving all Master Access File deficiencies, conducting appropriate biocompatibility and leachable testing under clinically relevant conditions, and thoroughly revising the product labeling to comply with all specified regulatory standards and guidance documents.