FDA WARNING_LETTER - Powers Device Technologies Inc - May 08, 2014

An FDA inspection of Powers Device Technologies, Inc. from May 7-8, 2014, revealed significant violations concerning their Pacifier Activated Lullaby (PAL?) device. The firm made substantial technological changes to the cleared device (K010388), including integrating speakers, changing power sources, and modifying pacifier connections, without obtaining new premarket clearance. Additionally, the firm marketed the device for new indications not covered by its original clearance, such as improving feeding ability and enhancing neural maturation. Consequently, the device was deemed adulterated under section 501(f)(1)(B) for lacking an approved PMA or IDE, and misbranded under section 502(o) for failing to submit a 510(k) for modifications. It was also misbranded under section 502(a) due to misleading labeling claiming "FDA-approved." Furthermore, the inspection identified several quality system deficiencies under 21 CFR Part 820, including failures to establish and maintain procedures for design control (820.30(a)(1)), corrective and preventive actions (820.100(a)), control of purchased products/services (820.50), complaint handling (820.198(a)), and quality audits (820.22). The firm must promptly correct these violations and provide a written response within 15 business days detailing corrective actions, preventive measures, and a timetable for completion, or face potential regulatory actions like seizure or injunction.