[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
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  Exemptions, variances, and alternative reporting requirements.

    (a) The following persons are exempt from the reporting requirements 
under this part.
    (1) An individual who is a licensed practitioner who prescribes or 
administers devices intended for use in humans and who 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 such person's use in research or teaching and not for 
sale, including any person who is subject to alternative reporting 
requirements under the investigational device exemption regulations, 
part 812 of this chapter, which require reporting of all adverse device 
effects.
    (3) Dental laboratories, or optical laboratories.
    (b) Manufacturers, importers, or user facilities may request 
exemptions or variances from any or all of the reporting requirements in 
this part. The request shall be in writing and include information 
necessary to identify the firm and device, a complete statement of the 
request for exemption, variance, or alternative reporting, and an 
explanation why the request is justified.
    (c) FDA may grant in writing, to a manufacturer, importer, or user 
facility, an exemption, variance, or alternative from, or 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. These modifications may be initiated by a request as 
specified in this section, or at

[[Page 47]]

the discretion of FDA. When granting such modifications, FDA may impose 
other reporting requirements to ensure the protection of public health.
    (d) FDA may revoke or modify in writing an exemption, variance, or 
alternative reporting requirements if FDA determines that protection of 
the public health justifies the modification or a return to the 
requirements as stated in this part.
    (e) Firms granted a reporting modification by FDA shall provide any 
reports or information required by that approval. The conditions of the 
approval will replace and supersede the reporting requirement specified 
in this part until such time that FDA revokes or modifies the 
alternative reporting requirements in accordance with paragraph (d) of 
this section.

[60 FR 63597, Dec. 11, 1995, as amended at 61 FR 44615, Aug. 28, 1996; 
65 FR 4119, Jan. 26, 2000; 65 FR 17136, Mar. 31, 2000; 66 FR 23157, May 
8, 2001]