[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR803.19]



[Page 46-47]

 

                        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 47]]



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.