Subsection Subsection Details Infractions
812.140 Records - Covers all subsections including those below 7
812.140(a) Investigator Records 28
812.140(a)(1) All correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, including required reports 8
812.140(a)(2) Records of receipt, use or disposition of a device 38
812.140(a)(2)(i) The type and quantity of the device, the dates of its receipt, and the batch number or code mark. 3
812.140(a)(2)(ii) The names of all persons who received, used, or disposed of each device 2
812.140(a)(2)(iii) Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of 3
812.140(a)(3) Records of each subject’s case history and exposure to the device 52
812.140 (a)(3)(i) Documents evidencing informed consent […] 21
812.140(a)(3)(ii) All relevant observations, including records concerning adverse device effects (whether anticipated or unanticipated), information and data on the condition of each subject upon entering, and during the course of, the investigation, including information about relevant previous medical history and the results of all diagnostic tests 11
812.140(a)(3)(iii) A record of the exposure of each subject to the investigational device, including the date and time of each use, and any other
812.140(a)(4) The protocol, with documents showing the dates of and reasons for each deviation from the protocol 5
812.140(a)(5) Any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigations or a
particular investigation
812.140(b) Sponsor records 1
812.140(b)(2) Records of shipment and disposition 2
812.140(b)(5) Records concerning adverse device effects (whether nticipated or unanticipated) and complaints and 1
812.140(d) Retention period 3
812.140(e) Records custody 2
Table 2: Detail of Infractions within Subsection 21 CFR 812.140. The range of infractions within this subsection can be generalized to documentation of device receipt, case histories and informed consent. 1996-Early 2011
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