[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.140]

[Page 118-119]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 812_INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
 
                      Subpart G_Records and Reports
 
Sec.  812.140  Records.


    (a) Investigator records. A participating investigator shall 
maintain the following accurate, complete, and current records relating 
to the investigator's participation in an investigation:
    (1) All correspondence with another investigator, an IRB, the 
sponsor, a monitor, or FDA, including required reports.
    (2) Records of receipt, use or disposition of a device that relate 
to:
    (i) The type and quantity of the device, the dates of its receipt, 
and the batch number or code mark.
    (ii) The names of all persons who received, used, or disposed of 
each device.
    (iii) Why and how many units of the device have been returned to the 
sponsor, repaired, or otherwise disposed of.
    (3) Records of each subject's case history and exposure to the 
device. Case histories include the case report forms and supporting data 
including, for example, signed and dated consent forms and medical 
records including, for example, progress notes of the physician, the 
individual's hospital chart(s), and the nurses' notes. Such records 
shall include:
    (i) Documents evidencing informed consent and, for any use of a 
device by the investigator without informed consent, any written 
concurrence of a licensed physician and a brief description of the 
circumstances justifying the failure to obtain informed consent. The 
case history for each individual shall document that informed consent 
was obtained prior to participation in the study.
    (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

[[Page 119]]

about relevant previous medical history and the results of all 
diagnostic tests.
    (iii) A record of the exposure of each subject to the 
investigational device, including the date and time of each use, and any 
other therapy.
    (4) The protocol, with documents showing the dates of and reasons 
for each deviation from the protocol.
    (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.
    (b) Sponsor records. A sponsor shall maintain the following 
accurate, complete, and current records relating to an investigation:
    (1) All correspondence with another sponsor, a monitor, an 
investigator, an IRB, or FDA, including required reports.
    (2) Records of shipment and disposition. Records of shipment shall 
include the name and address of the consignee, type and quantity of 
device, date of shipment, and batch number or code mark. Records of 
disposition shall describe the batch number or code marks of any devices 
returned to the sponsor, repaired, or disposed of in other ways by the 
investigator or another person, and the reasons for and method of 
disposal.
    (3) Signed investigator agreements including the financial 
disclosure information required to be collected under Sec.  812.43(c)(5) 
in accordance with part 54 of this chapter.
    (4) For each investigation subject to Sec.  812.2(b)(1) of a device 
other than a significant risk device, the records described in paragraph 
(b)(5) of this section and the following records, consolidated in one 
location and available for FDA inspection and copying:
    (i) The name and intended use of the device and the objectives of 
the investigation;
    (ii) A brief explanation of why the device is not a significant risk 
device:
    (iii) The name and address of each investigator:
    (iv) The name and address of each IRB that has reviewed the 
investigation:
    (v) A statement of the extent to which the good manufacturing 
practice regulation in part 820 will be followed in manufacturing the 
device; and
    (vi) Any other information required by FDA.
    (5) Records concerning adverse device effects (whether anticipated 
or unanticipated) and complaints and
    (6) Any other records that FDA requires to be maintained by 
regulation or by specific requirement for a category of investigation or 
a particular investigation.
    (c) IRB records. An IRB shall maintain records in accordance with 
part 56 of this chapter.
    (d) Retention period. An investigator or sponsor shall maintain the 
records required by this subpart during the investigation and for a 
period of 2 years after the latter of the following two dates: The date 
on which the investigation is terminated or completed, or the date that 
the records are no longer required for purposes of supporting a 
premarket approval application or a notice of completion of a product 
development protocol.
    (e) Records custody. An investigator or sponsor may withdraw from 
the responsibility to maintain records for the period required in 
paragraph (d) of this section and transfer custody of the records to any 
other person who will accept responsibility for them under this part, 
including the requirements of Sec.  812.145. Notice of a transfer shall 
be given to FDA not later than 10 working days after transfer occurs.

[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58843, Sept. 5, 1980; 46 
FR 8957, Jan. 27, 1981; 61 FR 57280, Nov. 5, 1996; 63 FR 5253, Feb. 2, 
1998]