FDA WARNING_LETTER - Axiobionics, LLC - July 25, 2012

The FDA issued a Warning Letter to Axiobionics following an inspection from June 18 to July 25, 2012, which found that their Wearable Therapy electrical stimulation garments are adulterated devices. The firm's manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Specific QS violations include failure to establish and maintain adequate procedures for design and development plans (21 CFR 820.30(b)), design changes (21 CFR 820.30(i)), design transfer (21 CFR 820.30(h)), production process control (21 CFR 820.70(a)), finished device acceptance (21 CFR 820.80(d)), device master records (21 CFR 820.181), and documentation of labels in device history records (21 CFR 820.120(d)).

Furthermore, Axiobionics is promoting and marketing its devices without required marketing clearance or approval. Significant changes to the device's design, components (e.g., from silver lycra to flexible coated wires), and intended uses (e.g., for stroke, cerebral palsy, chronic pain, spasticity, motor disorders) were made without submitting a new 510(k) application, as required by 21 CFR 807.81(a)(3). This renders the device adulterated under section 501(f)(1)(B) for lacking PMA/IDE approval and misbranded under section 502(o) for failing to notify the agency under 510(k).

The FDA requires prompt corrective action, a written response within fifteen business days detailing specific steps taken, preventative measures, and a timetable for completion. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts or future device approvals.