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Contains Nonbinding Recommendations

Section 513(a) of the FD&C Act (21 U.S.C. 360c(a)) establishes three classes of devices

based on the regulatory controls needed to provide reasonable assurance of their safety and

effectiveness: class I (general controls), class II (special controls in addition to general

controls), and class III (premarket approval in addition to general controls).

Under section 513(f) of the FD&C Act (21 U.S.C. 360c(f)), post-amendments devices

(devices that were not in commercial distribution before May 28, 1976, the date the Medical

Device Amendments were enacted) are classified in Class III. However, FDA may reclassify

a post- amendments device (as Class I or II) or determine that such a device is "substantially

equivalent" (SE)

to either another post-amendments device that has been classified into

Class I or II or to a pre-amendments device for which premarket approval is not required

Thus, a post-amendments device may be subject to regulation as a Class I or II device in

certain circumstances, including when:

· the device is within a type of device that has been classified into class I or II and FDA

has found the device to be SE to a device within such type;

· the device is within a type of pre-amendments device which is to be classified under

section 513(b) of the FD&C Act (21 U.S.C. 360c(b)) and FDA has found the device

to be SE to a device within such type (an unclassified device type); or

· FDA has classified or reclassified the device type in class I or II in accordance with

sections 513(f)(2) or 513(f)(3) of the FD&C Act (21 U.S.C. 360c(f)(2), (3)).

Pursuant to section 513(d) of the FD&C Act (21 U.S.C. 360c(d)), FDA promulgates

classification regulations classifying devices by generic type. A "generic type of device" is

"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." (See 21 CFR 860.3(i)). FDA has issued regulations classifying the vast

majority of pre- amendments devices (devices that were in commercial distribution before

May 28, 1976) by generic type of device. See 21 CFR 860.84. Each classification

regulation, located at 21 CFR parts 862-892, indicates in which class (I, II, or III) FDA has

Substantial equivalence is defined at section 513(i) of the FD&C Act (21 U.S.C. 360c(i)). FDA generally

evaluates substantial equivalence on the basis of a premarket notification submitted pursuant to section 510(k)

of the FD&C Act (21 U.S.C. 360(k)). Certain devices are subject to a statutory exemption from the 510(k)

premarket notification requirement (see sections 510(l) and (m) of the FD&C Act).

A pre-amendments device for which premarket approval is not required could be a pre-amendments device that

has been classified into Class I or Class II, a pre-amendments device that has been classified into Class III but for

which a regulation under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring the submission of an

application for premarket approval (PMA) has not yet been issued, or a pre-amendments device that has not yet

been classified.

Guidance For Industry And Food And Drug Administration Staff - U.s. Department Of Health And Human Services - 2012 Page 5