21 U.S.C. § 360l : US Code - Section 360L: Postmarket surveillance

Search 21 U.S.C. § 360l : US Code - Section 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.