FDA WARNING_LETTER - Schneider, Alan L.,M.D. - March 25, 2008

An FDA inspection from February 22 to March 25, 2008, at Dr. Alan L. Schneider's facility revealed serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects) related to his roles as sponsor and clinical investigator for two significant risk device studies.

As sponsor, Dr. Schneider failed to: - Include written monitoring procedures and ensure proper monitoring (21 CFR 812.25(e), 812.40, 812.43(d), 812.46). His response to use an outside monitoring group was inadequate without a qualification and oversight plan. - Obtain FDA and IRB approval for investigational plan changes prior to implementation, such as enrolling subjects on prohibited medications (21 CFR 812.35(a)(1)). His response lacked a plan for ensuring necessary approvals. - Submit timely progress reports to FDA (2003, 2005-2007) and a final report for one study, and any progress reports for the other (21 CFR 812.150(b)(5), 812.150(b)(7)). His response lacked a corrective plan for future reporting. - Notify FDA and IRBs of device repair requests (21 CFR