(a) Postmarket surveillance
(1) In general
(A) ConductThe Secretary may by order, at the time of approval or clearance of a device or at any time thereafter, require a manufacturer to conduct postmarket surveillance for any device of the manufacturer that is a class II or class III device—
(i)
the failure of which would be reasonably likely to have serious adverse health consequences;
(ii)
that is expected to have significant use in pediatric populations; or
(iii) that is intended to be—
(I)
implanted in the human body for more than 1 year; or
(II)
a life-sustaining or life-supporting
device used outside a
device user facility.
(B) Condition
The Secretary may order a postmarket surveillance under subparagraph (A) as a condition to approval or clearance of a device described in subparagraph (A)(ii).
(2) Rule of construction
The provisions of paragraph (1) shall have no effect on authorities otherwise provided under the chapter or regulations issued under this chapter.
(b) Surveillance approval
(1) In general
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 manufacturer shall commence surveillance under this section not later than 15 months after the day on which the Secretary issues an order under this section. Except as provided in paragraph (2), the Secretary, in consultation with the manufacturer, may by order require a prospective surveillance period of up to 36 months. Except as provided in paragraph (2), 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.
(2) Longer surveillance for pediatric devices
The Secretary may by order require a prospective surveillance period of more than 36 months with respect to a device that is expected to have significant use in pediatric populations if such period of more than 36 months is necessary in order to assess the impact of the device on growth and development, or the effects of growth, development, activity level, or other factors on the safety or efficacy of the device.
(June 25, 1938, ch. 675, § 522, as added
Pub. L. 101–629, § 10,
Nov. 28, 1990,
104 Stat. 4521; amended
Pub. L. 102–300, § 3(b),
June 16, 1992,
106 Stat. 239;
Pub. L. 105–115, title II, § 212,
Nov. 21, 1997,
111 Stat. 2346;
Pub. L. 110–85, title III, § 307,
Sept. 27, 2007,
121 Stat. 865;
Pub. L. 112–144, title VI, § 616,
July 9, 2012,
126 Stat. 1062.)
Amendments
2012—Subsec. (a)(1)(A). Pub. L. 112–144, § 616(1), inserted “, at the time of approval or clearance of a device or at any time thereafter,” after “by order” in introductory provisions.
Subsec. (b)(1). Pub. L. 112–144, § 616(2), inserted “The manufacturer shall commence surveillance under this section not later than 15 months after the day on which the Secretary issues an order under this section.” after “the public health.”
2007—Pub. L. 110–85, § 307(1), made technical amendment to section catchline.
Subsec. (a). Pub. L. 110–85, § 307(2), added subsec. (a) and struck out former subsec. (a). Prior to amendment, text read as follows: “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.”
Subsec. (b). Pub. L. 110–85, § 307(3), designated existing provisions as par. (1), inserted par. heading, substituted “Except as provided in paragraph (2), the Secretary, in consultation” for “The Secretary, in consultation” and “Except as provided in paragraph (2), any determination” for “Any determination”, and added par. (2).
Subsec. (c). Pub. L. 110–85, § 307(3)(D), added subsec. (c).
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.”
Study by Institute of Medicine of Postmarket Surveillance Regarding Pediatric Populations
Pub. L. 107–250, title II, § 212, Oct. 26, 2002, 116 Stat. 1614, as amended by Pub. L. 108–214, § 2(d)(3)(C), Apr. 1, 2004, 118 Stat. 577, provided that the Secretary of Health and Human Services would request the Institute of Medicine to study whether the system under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) for the postmarket surveillance of medical devices provides adequate safeguards regarding the use of devices in pediatric populations, and provided that the Secretary, not later than four years after Oct. 26, 2002, would submit to Congress a report on the study and legislative and administrative recommendations.
{'misc': '', 'cleanpath': '/uscode/text/21/360l', 'headtext': ' Postmarket surveillance', 'cfr_titles': [{'title': '21', 'parts': [{'part': '4', 'cleanpath': '/cfr/text/21/part-4', 'headtext': 'REGULATION OF COMBINATION PRODUCTS'}, {'part': '5', 'cleanpath': '/cfr/text/21/part-5', 'headtext': 'ORGANIZATION'}, {'part': '7', 'cleanpath': '/cfr/text/21/part-7', 'headtext': 'ENFORCEMENT POLICY'}, {'part': '10', 'cleanpath': '/cfr/text/21/part-10', 'headtext': 'ADMINISTRATIVE PRACTICES AND PROCEDURES'}, {'part': '11', 'cleanpath': '/cfr/text/21/part-11', 'headtext': 'ELECTRONIC RECORDS; ELECTRONIC SIGNATURES'}, {'part': '12', 'cleanpath': '/cfr/text/21/part-12', 'headtext': 'FORMAL EVIDENTIARY PUBLIC HEARING'}, {'part': '13', 'cleanpath': '/cfr/text/21/part-13', 'headtext': 'PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY'}, {'part': '14', 'cleanpath': '/cfr/text/21/part-14', 'headtext': 'PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE'}, {'part': '15', 'cleanpath': '/cfr/text/21/part-15', 'headtext': 'PUBLIC HEARING BEFORE THE COMMISSIONER'}, {'part': '16', 'cleanpath': '/cfr/text/21/part-16', 'headtext': 'REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION'}, {'part': '20', 'cleanpath': '/cfr/text/21/part-20', 'headtext': 'PUBLIC INFORMATION'}, {'part': '25', 'cleanpath': '/cfr/text/21/part-25', 'headtext': 'ENVIRONMENTAL IMPACT CONSIDERATIONS'}, {'part': '26', 'cleanpath': '/cfr/text/21/part-26', 'headtext': 'MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY'}, {'part': '820', 'cleanpath': '/cfr/text/21/part-820', 'headtext': 'QUALITY SYSTEM REGULATION'}, {'part': '822', 'cleanpath': '/cfr/text/21/part-822', 'headtext': 'POSTMARKET SURVEILLANCE'}, {'part': '862', 'cleanpath': '/cfr/text/21/part-862', 'headtext': 'CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES'}, {'part': '866', 'cleanpath': '/cfr/text/21/part-866', 'headtext': 'IMMUNOLOGY AND MICROBIOLOGY DEVICES'}, {'part': '868', 'cleanpath': '/cfr/text/21/part-868', 'headtext': 'ANESTHESIOLOGY DEVICES'}, {'part': '870', 'cleanpath': '/cfr/text/21/part-870', 'headtext': 'CARDIOVASCULAR DEVICES'}, {'part': '876', 'cleanpath': '/cfr/text/21/part-876', 'headtext': 'GASTROENTEROLOGY-UROLOGY DEVICES'}, {'part': '878', 'cleanpath': '/cfr/text/21/part-878', 'headtext': 'GENERAL AND PLASTIC SURGERY DEVICES'}, {'part': '880', 'cleanpath': '/cfr/text/21/part-880', 'headtext': 'GENERAL HOSPITAL AND PERSONAL USE DEVICES'}, {'part': '882', 'cleanpath': '/cfr/text/21/part-882', 'headtext': 'NEUROLOGICAL DEVICES'}, {'part': '884', 'cleanpath': '/cfr/text/21/part-884', 'headtext': 'OBSTETRICAL AND GYNECOLOGICAL DEVICES'}, {'part': '886', 'cleanpath': '/cfr/text/21/part-886', 'headtext': 'OPHTHALMIC DEVICES'}, {'part': '890', 'cleanpath': '/cfr/text/21/part-890', 'headtext': 'PHYSICAL MEDICINE DEVICES'}, {'part': '892', 'cleanpath': '/cfr/text/21/part-892', 'headtext': 'RADIOLOGY DEVICES'}]}], 'section': '360l'}