FDA WARNING_LETTER - Market Technologies Inc. DBA Dermavista - May 09, 2013

Market Technologies Inc., dba Dermavista, a manufacturer and initial importer of Class I and Class II aesthetic medical devices, received an FDA Warning Letter following an inspection on April 25 and May 8-9, 2013. The inspection revealed significant violations across Medical Device Reporting (MDR), unapproved device marketing, and Quality System Regulation (QSR) requirements.

Regarding MDR, the firm's devices were deemed misbranded under Section 502(t)(2) of the Act due to a failure to develop, maintain, and implement written MDR procedures (21 CFR 803.17). Deficiencies included inadequate internal systems for event identification, evaluation, timely transmission of reports, and documentation/record-keeping.

Additionally, the firm was found to be marketing multiple devices (Contour Ultra, Vascutouch, Starpress, SW Ultrasound Basic, SW Ultrasound RF, Diamond Medilift, and Stratapulse IPL) without appropriate marketing approval, rendering them adulterated under Section 501(f)(1)(B) and misbranded under Section 502(o) of the Act. This included lacking PMA/IDE approval or 510(k) clearance, or marketing devices with major changes to intended use or design modifications without new premarket notifications.

Quality System Regulation violations (21 CFR Part 820) included failures to establish procedures for corrective and preventive action (CAPA), complaint handling, acceptance activities, purchasing controls, quality audits, management review, personnel training, and document control. The FDA deemed the firm's responses to the Form FDA 483 inadequate for several issues.

The FDA requires prompt corrective action within 15 working days, including a written response detailing steps taken, preventive measures, documentation, and a timetable for completion. Failure to comply may result in regulatory actions such as seizure, injunction, or civil money penalties, and could impact federal contracts.