[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: 21CFR812.2]



[Page 99-100]

 

                        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 A_General Provisions

 

Sec.  812.2  Applicability.



    (a) General. This part applies to all clinical investigations of 

devices to determine safety and effectiveness, except as provided in 

paragraph (c) of this section.

    (b) Abbreviated requirements. The following categories of 

investigations are considered to have approved applications for IDE's, 

unless FDA has notified a sponsor under Sec.  812.20(a) that approval of 

an application is required:

    (1) An investigation of a device other than a significant risk 

device, if the device is not a banned device and the sponsor:

    (i) Labels the device in accordance with Sec.  812.5;

    (ii) Obtains IRB approval of the investigation after presenting the 

reviewing IRB with a brief explanation of why the device is not a 

significant risk device, and maintains such approval;

    (iii) Ensures that each investigator participating in an 

investigation of the device obtains from each subject under the 

investigator's care, informed consent under part 50 and documents it, 

unless documentation is waived by an IRB under Sec.  56.109(c).

    (iv) Complies with the requirements of Sec.  812.46 with respect to 

monitoring investigations;

    (v) Maintains the records required under Sec.  812.140(b) (4) and 

(5) and makes the reports required under Sec.  812.150(b) (1) through 

(3) and (5) through (10);

    (vi) Ensures that participating investigators maintain the records 

required by Sec.  812.140(a)(3)(i) and make the reports required under 

Sec.  812.150(a) (1), (2), (5), and (7); and

    (vii) Complies with the prohibitions in Sec.  812.7 against 

promotion and other practices.

    (2) An investigation of a device other than one subject to paragraph 

(e) of this section, if the investigation was begun on or before July 

16, 1980, and to be completed, and is completed, on or before January 

19, 1981.

    (c) Exempted investigations. This part, with the exception of Sec.  

812.119, does not apply to investigations of the following categories of 

devices:

    (1) A device, other than a transitional device, in commercial 

distribution immediately before May 28, 1976, when used or investigated 

in accordance with the indications in labeling in effect at that time.

    (2) A device, other than a transitional device, introduced into 

commercial distribution on or after May 28, 1976, that FDA has 

determined to be substantially equivalent to a device in commercial 

distribution immediately before May 28, 1976, and that is used or 

investigated in accordance with the indications in the labeling FDA 

reviewed under subpart E of part 807 in determining substantial 

equivalence.

    (3) A diagnostic device, if the sponsor complies with applicable 

requirements in Sec.  809.10(c) and if the testing:

    (i) Is noninvasive,

    (ii) Does not require an invasive sampling procedure that presents 

significant risk,

    (iii) Does not by design or intention introduce energy into a 

subject, and

    (iv) Is not used as a diagnostic procedure without confirmation of 

the diagnosis by another, medically established diagnostic product or 

procedure.

    (4) A device undergoing consumer preference testing, testing of a 

modification, or testing of a combination of two or more devices in 

commercial distribution, if the testing is not for the purpose of 

determining safety or effectiveness and does not put subjects at risk.

    (5) A device intended solely for veterinary use.

    (6) A device shipped solely for research on or with laboratory 

animals and labeled in accordance with Sec.  812.5(c).



[[Page 100]]



    (7) A custom device as defined in Sec.  812.3(b), unless the device 

is being used to determine safety or effectiveness for commercial 

distribution.

    (d) Limit on certain exemptions. In the case of class II or class 

III device described in paragraph (c)(1) or (2) of this section, this 

part applies beginning on the date stipulated in an FDA regulation or 

order that calls for the submission of premarket approval applications 

for an unapproved class III device, or establishes a performance 

standard for a class II device.

    (e) Investigations subject to IND's. A sponsor that, on July 16, 

1980, has an effective investigational new drug application (IND) for an 

investigation of a device shall continue to comply with the requirements 

of part 312 until 90 days after that date. To continue the investigation 

after that date, a sponsor shall comply with paragraph (b)(1) of this 

section, if the device is not a significant risk device, or shall have 

obtained FDA approval under Sec.  812.30 of an IDE application for the 

investigation of the device.



[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 46 

FR 14340, Feb. 27, 1981; 53 FR 11252, Apr. 6, 1988; 62 FR 4165, Jan, 29, 

1997; 62 FR 12096, Mar. 14, 1997]