[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: 21CFR874.9]

[Page 347-348]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 874--EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 874.9  Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce for 
commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays

[[Page 348]]

when the results are not qualitative, or are used to determine immunity, 
or the assay is intended for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2315, Jan. 14, 2000]