FDA WARNING_LETTER - The Judge Rotenberg Educational Center, Inc. - October 17, 2012

The FDA issued a Warning Letter to The Judge Rotenberg Educational Center following an inspection from October 3-17, 2012. The inspection revealed the facility possessed an inventory of Graduated Electronic Decelerators (GED) 3A and GED4 devices, with use authorized for 27 students. The FDA had previously notified the facility on May 23, 2011, and June 29, 2012, that modifications to the original GED device required a new premarket notification under 21 CFR 807.81(a)(3).

Consequently, the GED3A and GED4 devices are deemed adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 351(f)(1)(B), because the facility lacks an approved premarket approval application (section 515(a)) or an approved investigational device exemption (section 520(g)). Despite the facility's stated plan to submit a 510(k) by December 2012, no submission has been received.

The FDA requires prompt corrective action to address these violations. Failure to comply may result in regulatory actions including seizure, injunction, civil money penalties, and federal agencies being advised of the Warning Letter for contract considerations. The facility must respond