FDA WARNING_LETTER - Medivance Instruments Ltd. - August 11, 2022

On February 13, 2023, the FDA issued a Warning Letter to Barretts Green Road, Harlesden, London, United Kingdom, following an inspection from August 8-11, 2022. The inspection revealed that the firm's Velopex Aquacut Fluid Abrasion Unit and accessories (Velopex Device), intended for dental procedures, are adulterated and misbranded.

The Velopex Device, cleared via 510(k) (K024105) in 2003, underwent significant design changes (e.g., new air regulator, altered powder tubing/valve materials) without a new 510(k) submission, rendering the modified devices misbranded under 21 U.S.C. § 352(o) and adulterated under 21 U.S.C. § 351(f)(1)(B).

Furthermore, the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Specific QS violations include: 1. **Failure to control design changes (21 CFR 820.30(i)):** Lack of procedures for validating/verifying design changes before implementation, and inadequate documentation of past validations.