[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: 21CFR1000.60]

[Page 577]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1000--GENERAL--Table of Contents
 
             Subpart C--Radiation Protection Recommendations
 
Sec. 1000.60  Recommendation on administratively required dental x-ray examinations.

    (a) The Food and Drug Administration recommends that dental x-ray 
examinations be performed only after careful consideration of the dental 
or other health needs of the patient, that is, when the patient's 
dentist or physician judges them to be necessary for diagnosis, 
treatment, or prevention of disease. Administratively required dental x-
ray examinations are those required by a remote third party for reasons 
not related to the patient's immediate dental needs. These x-ray 
examinations are usually a source of unnecessary radiation exposure to 
the patient. Because any unnecessary radiation exposure should be 
avoided, third parties should not require dental x-ray examinations 
unless they can demonstrate that such examinations provide a direct 
clinical benefit to the patient, and the patient's dentist or physician 
agrees with that assessment.
    (b) Some examples of administrative x-ray examinations that should 
not be required by third parties are those intended solely:
    (1) To monitor insurance claims or detect fraud;
    (2) To satisfy a prerequisite for reimbursement;
    (3) To provide training or experience;
    (4) To certify qualifications or competence.
    (c) This recommendation is not intended to preclude dental x-ray 
examinations ordered by the attending practitioner, based on the 
patient's history or physical examination, or those performed on 
selected populations shown to have significant yields of previously 
undiagnosed disease. This recommendation is also not intended to 
preclude the administrative use by third parties of dental radiographs 
that are taken on the order of the patient's dentist or physician as a 
necessary part of the patient's clinical care.

[45 FR 40978, June 17, 1980]