§ 860.3 - Definitions.

§ 860.3 Definitions.

Cross Reference

Link to an amendment published at 86 FR 54846, Oct. 5, 2021.

For the purposes of this part:

(a) Act means the Federal Food, Drug, and Cosmetic Act.

(b) Commissioner means the Commissioner of Food and Drugs, Food and Drug Administration, United States Department of Health and Human Services, or the Commissioner's designee.

(c)

Class means one of the three categories of regulatory control for medical devices, defined

below

as follows:

(1)

Class I means the class of devices that are subject only to

only

the general controls authorized by or under sections 501 (adulteration), 502 (misbranding), 510 (registration), 516 (banned devices), 518 (notification and other remedies), 519 (records and reports), and 520 (general provisions) of the

act

Federal Food, Drug, and Cosmetic Act. A device is in class I if:

(

i

1)

general

General controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, or

(

ii

2)

there

There is insufficient information from which to determine that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but the device is not life-supporting or life-sustaining, or for a use which is of

substanial

substantial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness

of

or injury.

(2)

Class II means the class of devices that is or eventually will be subject to special controls. A device is in class II if general controls alone are insufficient to provide reasonable assurance of its safety and effectiveness and there is sufficient information to establish special controls, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of

guidance documents

guidelines (including

guidance on

guidelines for the submission of clinical data in premarket notification submissions in accordance with section 510(k) of the

act

Federal Food, Drug, and Cosmetic Act), recommendations, and other appropriate actions as the Commissioner deems necessary to provide such assurance. For a device that is purported or represented to be for use in supporting or sustaining human life, the Commissioner shall examine and identify the special controls, if any,

that

which are necessary to provide adequate assurance of safety and effectiveness, and describe how such controls provide such assurance.

(3)

Class III means the class of devices for which premarket approval is or will be required in accordance with section 515 of the

act

Federal Food, Drug, and Cosmetic Act. A device is in class III if insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness, or that application of special controls described in

paragraph (c)(2) of this section

the definition of “Class II” in this section in addition to general controls, would provide such assurance, and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury.

(d)

Classification panel means one of the several advisory committees established by the Commissioner under section 513 of the Federal Food, Drug, and Cosmetic Act and part 14 of this chapter for the purpose of making recommendations to the Commissioner on the classification and reclassification of devices and for other purposes prescribed by the Federal Food, Drug, and Cosmetic Act or by the Commissioner.

Classification regulation means a section under parts 862 through 892 of this chapter that contains the identification (general description and intended use) and classification (class I, II or III) of a single device type or more than one related device type(s).

Commissioner means the Commissioner of Food and Drugs, Food and Drug Administration, United States Department of Health and Human Services, or the Commissioner's designee.

De Novo request means any submission under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act for a medical device, requesting classification into class I or class II, including all information submitted with or incorporated by reference therein.

FDA means the Food and Drug Administration.

General controls mean the controls authorized by or under sections 501 (adulteration), 502 (misbranding), 510 (registration, listing, and premarket notification), 516 (banned devices), 518 (notification and other remedies), 519 (records, reports, and unique device identification), and 520 (general provisions) of the Federal Food, Drug, and Cosmetic Act.

Generic type of device means a grouping of devices that do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness.

Implant means a device that is placed into a surgically or naturally formed cavity of the human body. A device is regarded as an implant for the purpose of this part only if it is intended to remain implanted continuously for a period of 30 days or more, unless the Commissioner determines otherwise

in order

to protect human health.

(e)

Life-supporting or life-sustaining device means a device that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life.

(f)-(g) [Reserved]

(h) Classification panel means one of the several advisory committees established by the Commissioner under section 513 of the act and part 14 of this chapter for the purpose of making recommendations to the Commissioner on the classification and reclassification of devices and for other purposes prescribed by the act or by the Commissioner.

(i) Generic type of device means a grouping of devices that do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness.

(j) Petition means a submission seeking reclassification of a device in accordance with § 860.123.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58403, Dec. 10, 1992; 65 FR 56480, Sept. 19, 2000; 83 FR 64454, Dec. 17, 2018

Petition means a submission seeking reclassification of a device in accordance with § 860.123.

Special controls mean the controls necessary to provide reasonable assurance of safety and effectiveness for a generic type of device that is class II. Special controls include performance standards, performance testing, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 510(k) of the Federal Food, Drug, and Cosmetic Act), recommendations, and other appropriate actions, as the Commissioner deems necessary to provide such assurance.

[86 FR 54846, Oct. 5, 2021]