[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.84]

[Page 131]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES--Table of Contents
 
                  Subpart E--Postapproval Requirements
 
Sec. 814.84  Reports.

    (a) The holder of an approved PMA shall comply with the requirements 
of part 803 and with any other requirements applicable to the device by 
other regulations in this subchapter or by order approving the device.
    (b) Unless FDA specifies otherwise, any periodic report shall:
    (1) Identify changes described in Sec. 814.39(a) and changes 
required to be reported to FDA under Sec. 814.39(b).
    (2) Contain a summary and bibliography of the following information 
not previously submitted as part of the PMA:
    (i) Unpublished reports of data from any clinical investigations or 
nonclinical laboratory studies involving the device or related devices 
and known to or that reasonably should be known to the applicant.
    (ii) Reports in the scientific literature concerning the device and 
known to or that reasonably should be known to the applicant. If, after 
reviewing the summary and bibliography, FDA concludes that the agency 
needs a copy of the unpublished or published reports, FDA will notify 
the applicant that copies of such reports shall be submitted.

(Approved by the Office of Management and Budget under control number 
0910-0231)

[51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986]

Subparts F-G  [Reserved]