United Health Products, 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 submit an IDE application to FDA and failure to obtain FDA approval prior to beginning an investigation for which FDA’s approval is required [21 CFR 812.20(a)(1) and (2).

Passage 2

Failure to ensure proper monitoring of the investigation [21 CFR 812.40].

Passage 3

Failure to secure clinical investigator’s compliance with the signed agreement, the investigational plan, applicable FDA regulations, and any other conditions of approval imposed by the reviewing IRB or FDA, or if compliance could not be obtained, failure to discontinue shipments of the device to the investigator and terminate the investigator’s participation in the investigation [21 CFR 812.46(a)].

Passage 4

Failure to immediately conduct an evaluation of any unanticipated adverse device effects and failure to report results of such an evaluation to FDA and to all reviewing IRB’s and participating investigators within 10 working days [21 CFR 812.46(b)(1) and 21 CFR 812.150(b)(1)].

Passage 5

Failure to maintain accurate, complete, and current device shipment and disposition records [21 CFR 812.140(b)(2)].