[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.3]

[Page 393-394]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 878_GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 878.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the

[[Page 394]]

regulation classifying the device unless the manufacturer has an 
approval under section 515 of the act (unless an exemption has been 
granted under section 520(g)(2) of the act). An approval under section 
515 of the act consists of FDA's issuance of an order approving an 
application for premarket approval (PMA) for the device or declaring 
completed a product development protocol (PDP) for the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act, FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraphs (b) and (c) of this section. Such a regulation under section 
515(b) of the act shall not be effective during the grace period ending 
on the 90th day after its promulgation or on the last day of the 30th 
full calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.
    (c) A device identified in a regulation in this part that is 
classified into class III and that is subject to the transitional 
provisions of section 520(l) of the act is automatically classified by 
statute into class III and must have an approval under section 515 of 
the act before being commercially distributed. Accordingly, the 
regulation for such a class III transitional device states that as of 
the enactment date of the amendments, May 28, 1976, the device must have 
an approval under section 515 of the act before commercial distribution.