[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.82]

[Page 144]
 
                        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. 814.82  Postapproval requirements.

    (a) FDA may impose postapproval requirements in a PMA approval order 
or by regulation at the time of approval of the PMA or by regulation 
subsequent to approval. Postapproval requirements may include as a 
condition to approval of the device:
    (1) Restriction of the sale, distribution, or use of the device as 
provided by section 515(d)(1)(B)(ii) or 520(e) of the act.
    (2) Continuing evaluation and periodic reporting on the safety, 
effectiveness, and reliability of the device for its intended use. FDA 
will state in the PMA approval order the reason or purpose for such 
requirement and the number of patients to be evaluated and the reports 
required to be submitted.
    (3) Prominent display in the labeling of a device and in the 
advertising of any restricted device of warnings, hazards, or 
precautions important for the device's safe and effective use, including 
patient information, e.g., information provided to the patient on 
alternative modes of therapy and on risks and benefits associated with 
the use of the device.
    (4) Inclusion of identification codes on the device or its labeling, 
or in the case of an implant, on cards given to patients if necessary to 
protect the public health.
    (5) Maintenance of records that will enable the applicant to submit 
to FDA information needed to trace patients if such information is 
necessary to protect the public health. Under section 519(a)(4) of the 
act, FDA will require that the identity of any patient be disclosed in 
records maintained under this paragraph only to the extent required for 
the medical welfare of the individual, to determine the safety or 
effectiveness of the device, or to verify a record, report, or 
information submitted to the agency.
    (6) Maintenance of records for specified periods of time and 
organization and indexing of records into identifiable files to enable 
FDA to determine whether there is reasonable assurance of the continued 
safety and effectiveness of the device.
    (7) Submission to FDA at intervals specified in the approval order 
of periodic reports containing the information required by Sec. 
814.84(b).
    (8) Batch testing of the device.
    (9) Such other requirements as FDA determines are necessary to 
provide reasonable assurance, or continued reasonable assurance, of the 
safety and effectiveness of the device.
    (b) An applicant shall grant to FDA access to any records and 
reports required under the provisions of this part, and shall permit 
authorized FDA employees to copy and verify such records and reports and 
to inspect at a reasonable time and in a reasonable manner all 
manufacturing facilities to verify that the device is being 
manufactured, stored, labeled, and shipped under approved conditions.
    (c) Failure to comply with any postapproval requirement constitutes 
a ground for withdrawal of approval of a PMA.

(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]