[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.19]

[Page 51-52]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 803_MEDICAL DEVICE REPORTING--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  803.19  Are there exemptions, variances, or alternative forms of adverse 

event reporting requirements?

    (a) We exempt the following persons from the adverse event reporting 
requirements in this part:
    (1) A licensed practitioner who prescribes or administers devices 
intended for use in humans and manufactures or imports devices solely 
for use in diagnosing and treating persons with whom the practitioner 
has a ``physician-patient'' relationship;
    (2) An individual who manufactures devices intended for use in 
humans solely for this person's use in research or teaching and not for 
sale. This includes any person who is subject to alternative reporting 
requirements under the investigational device exemption regulations 
(described in part 812 of

[[Page 52]]

this chapter), which require reporting of all adverse device effects; 
and
    (3) Dental laboratories or optical laboratories.
    (b) If you are a manufacturer, importer, or user facility, you may 
request an exemption or variance from any or all of the reporting 
requirements in this part. You must submit the request to us in writing. 
Your request must include information necessary to identify you and the 
device; a complete statement of the request for exemption, variance, or 
alternative reporting; and an explanation why your request is justified.
    (c) If you are a manufacturer, importer, or user facility, we may 
grant in writing an exemption or variance from, or alternative to, any 
or all of the reporting requirements in this part and may change the 
frequency of reporting to quarterly, semiannually, annually or other 
appropriate time period. We may grant these modifications in response to 
your request, as described in paragraph (b) of this section, or at our 
discretion. When we grant modifications to the reporting requirements, 
we may impose other reporting requirements to ensure the protection of 
public health.
    (d) We may revoke or modify in writing an exemption, variance, or 
alternative reporting requirement if we determine that revocation or 
modification is necessary to protect the public health.
    (e) If we grant your request for a reporting modification, you must 
submit any reports or information required in our approval of the 
modification. The conditions of the approval will replace and supersede 
the regular reporting requirement specified in this part until such time 
that we revoke or modify the alternative reporting requirements in 
accordance with paragraph (d) of this section.