Nobles Medical Technology II, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to ensure proper monitoring and Institutional Review Board (IRB) review and approval [21 CFR 812.40].

Passage 2

Failure to select qualified investigators and monitors by training and experience for conducting of a study [812.43(a) and (d)].

Passage 3

Failure to obtain a signed agreement from each participating investigator that includes a statement of the investigator’s commitment to conduct an investigation in accordance with the agreement, investigational plan, applicable FDA regulations, conditions of approval imposed by the reviewing IRB and conditions of approval imposed by the FDA [21 CFR 812.43(c)(4)(i)].

Passage 4

Failure to obtain from each participating investigator a signed agreement that includes sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement [21 CFR 812.43(c)(5)].

Passage 5

You failed to obtain a signed agreement that includes sufficient accurate financial disclosure information from each participating investigator. Specifically, you did not provide financial disclosure records for any site during your inspection. Obtaining accurate financial disclosure information is important for ensuring that there is no financial bias by any of your clinical investigators that may impact clinical study data.