[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.126]

[Page 145-146]
 
                        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 H_Humanitarian Use Devices
 
Sec. 814.126  Postapproval requirements and reports.

    (a) An HDE approved under this subpart H shall be subject to the 
postapproval requirements and reports set forth under subpart E of this 
part, as applicable, with the exception of Sec. 814.82(a)(7). In 
addition, medical device reports submitted to FDA in compliance with the 
requirements of part 803 of this chapter shall also be submitted to the 
IRB of record.
    (b) In addition to the reports identified in paragraph (a) of this 
section, the holder of an approved HDE shall prepare and submit the 
following complete, accurate, and timely reports:
    (1) Periodic reports. An HDE applicant is required to submit reports 
in accordance with the approval order. Unless FDA specifies otherwise, 
any periodic report shall include:
    (i) An update of the information required under Sec. 814.102(a) in 
a separately bound volume;
    (ii) An update of the information required under Sec. 
814.104(b)(2), (b)(3), and (b)(5);
    (iii) The number of devices that have been shipped or sold since 
initial marketing approval under this subpart H and, if the number 
shipped or sold exceeds 4,000, an explanation and estimate of the number 
of devices used per patient. If a single device is used on multiple 
patients, the applicant shall submit an estimate of the number of 
patients treated or diagnosed using the device together with an 
explanation of the basis for the estimate;
    (iv) Information describing the applicant's clinical experience with 
the device since the HDE was initially approved. This information shall 
include safety information that is known or reasonably should be known 
to the applicant, medical device reports made under part 803 of this 
chapter, any data generated from the postmarketing studies, and 
information (whether published or unpublished) that is known or 
reasonably expected to be known by the applicant that may affect an 
evaluation of the safety of the device or that may affect the statement 
of contraindications, warnings, precautions, and adverse reactions in 
the device's labeling; and

[[Page 146]]

    (v) A summary of any changes made to the device in accordance with 
supplements submitted under Sec. 814.108. If information provided in 
the periodic reports, or any other information in the possession of FDA, 
gives the agency reason to believe that a device raises public health 
concerns or that the criteria for exemption are no longer met, the 
agency may require the HDE holder to submit additional information to 
demonstrate continued compliance with the HDE requirements.
    (2) Other. An HDE holder shall maintain records of the names and 
addresses of the facilities to which the HUD has been shipped, 
correspondence with reviewing IRB's, as well as any other information 
requested by a reviewing IRB or FDA. Such records shall be maintained in 
accordance with the HDE approval order.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998, 71 
FR 16228, Mar. 31, 2006]