[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR892.3]

[Page 514-515]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 892--RADIOLOGY DEVICES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 892.3  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 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 
paragraph (b) 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

[[Page 515]]

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.