
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360l]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 360l. Postmarket surveillance


(a) In general

    The Secretary may by order require a manufacturer to conduct 
postmarket surveillance for any device of the manufacturer which is a 
class II or class III device the failure of which would be reasonably 
likely to have serious adverse health consequences or which is intended 
to be--
        (1) implanted in the human body for more than one year, or
        (2) a life sustaining or life supporting device used outside a 
    device user facility.

(b) Surveillance approval

    Each manufacturer required to conduct a surveillance of a device 
shall, within 30 days of receiving an order from the Secretary 
prescribing that the manufacturer is required under this section to 
conduct such surveillance, submit, for the approval of the Secretary, a 
plan for the required surveillance. The Secretary, within 60 days of the 
receipt of such plan, shall determine if the person designated to 
conduct the surveillance has appropriate qualifications and experience 
to undertake such surveillance and if the plan will result in the 
collection of useful data that can reveal unforeseen adverse events or 
other information necessary to protect the public health. The Secretary, 
in consultation with the manufacturer, may by order require a 
prospective surveillance period of up to 36 months. Any determination by 
the Secretary that a longer period is necessary shall be made by mutual 
agreement between the Secretary and the manufacturer or, if no agreement 
can be reached, after the completion of a dispute resolution process as 
described in section 360bbb-1 of this title.

(June 25, 1938, ch. 675, Sec. 522, as added Pub. L. 101-629, Sec. 10, 
Nov. 28, 1990, 104 Stat. 4521; amended Pub. L. 102-300, Sec. 3(b), June 
16, 1992, 106 Stat. 239; Pub. L. 105-115, title II, Sec. 212, Nov. 21, 
1997, 111 Stat. 2346.)


                               Amendments

    1997--Pub. L. 105-115 amended section generally, substituting 
present provisions for former provisions which related to required 
surveillance, discretionary surveillance, and surveillance approval.
    1992--Subsec. (b). Pub. L. 102-300 substituted ``(a)(1)'' for 
``(a)'', inserted comma after ``commerce'', and inserted after first 
sentence ``Each manufacturer required to conduct a surveillance of a 
device under subsection (a)(2) of this section shall, within 30 days 
after receiving notice that the manufacturer is required to conduct such 
surveillance, submit, for the approval of the Secretary, a protocol for 
the required surveillance.''


                    Effective Date of 1997 Amendment

    Section 212 of Pub. L. 105-115 provided in part that the amendment 
made by that section is effective 90 days after Nov. 21, 1997.

                  Section Referred to in Other Sections

    This section is referred to in sections 331, 352 of this title.
