Warning Letter — ZIIP, Inc.
The FDA issued a Warning Letter to ZIIP, Inc. on May 22, 2026, following an evaluation by the Center for Devices and Radiological Health regarding the company's compliance with federal regulations.
This notice affects ZIIP, Inc., as well as regulatory and quality departments within medical device companies specializing in home-use or aesthetic electronic devices.
The issuance of a Warning Letter by CDRH typically indicates significant deviations from the Federal Food, Drug, and Cosmetic Act, such as marketing a device without required clearance or approval (adulteration/misbranding). This suggests that the firm's current marketing or device specifications may have exceeded the scope of their existing regulatory filings.
Firms should immediately review all marketing materials and product claims to ensure they align with the cleared indications for use. If device modifications or new intended uses are identified, regulatory teams must determine if a new 510(k) submission is required before continuing commercial distribution.
FDA Warning Letter issued to: ZIIP, Inc.. 05/22/2026 — Center for Devices and Radiological Health. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ziip-inc-725870-05222026
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