[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR812.140]



[Page 113-114]

 

                        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 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,



[[Page 114]]



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]