Public Law 102–300

in subsection (b)(3), by striking out “upon the effective date” and inserting in lieu thereof “upon the expiration of 9 months after the issuance”;

in subsection (c)(2)—

by adding at the end of subsection (c) the following:

“(3)“(3)

Not later than November 28, 1992, the Secretary shall issue final regulations to implement section 519(e) of the Federal Food, Drug, and Cosmetic Act If the Secretary does not promulgate such final regulations by November 28, 1992, the Congress finds that there is good cause for the proposed regulations to be considered as the final regulations without response to comment because the implementation of section 519(e) of such Act is essential to protect the health of patients who use devices. In such event, the proposed regulations issued under paragraph (1) shall become the issued final regulations

Federal Register, publication.

on November 29, 1992. There shall be promptly published in the Federal Register notice of the new status of the proposed regulations.”.

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In general.—

Section 301(q)(1) (21 U.S.C. 331(q)(1)) is amended—

Misbranded devices.—

Section 502(t) (21 U.S.C. 352(t)) is amended—

by striking out “(a)” and inserting in lieu thereof “(a)(1)”;

by inserting a comma after “commerce”; and

by adding after the first sentence the following: “Each manufacturer required to conduct a surveillance of a device under subsection (a)(2) 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.”.

by redesignating paragraphs (1) through (6) of subsection (a) as paragraphs (4) through (9), respectively, and by inserting before paragraph (4) (as so redesignated) the following:

“(1)“(1)

shall require a device manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices—

“(A)“(A)

may have caused or contributed to a death or serious injury, or

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“(B)“(B)

has malfunctioned and that such device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur;

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“(2)“(2)

shall define the term ‘serious injury’ to mean an injury that—

“(A)“(A)

is life threatening,

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“(B)“(B)

results in permanent impairment of a body function or permanent damage to a body structure, or

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“(C)“(C)

necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure;

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“(3)“(3)

shall require reporting of other significant adverse device experiences as determined by the Secretary to be necessary to be reported;”; and

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in subsection (b)—

1 year after the date of the enactment of this Act; or

on the effective date of regulations of the Secretary to implement such amendments,

in subsection (h), by striking out “any of its principal” and inserting in lieu thereof “its primary”; and

by adding at the end the following:

“(ff)“(ff)

The term ‘Commissioner’ means the Commissioner of Food and Drugs.”

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Subsections (c) and (d) of sections 201, subsections (a), (d), (h), (i), (1), (m), and (o) of section 408, subsections (a) and (b) of section 536, section 701(b), and subsections (a) and (b) of section 801 (21 U.S.C. 321 (c) and (d), 346a (a), (d), (h), (i), (1), (m), and (o), 360mm (a) and (b), 371(b), and 381 (a) and (b)) and section 351(c) of the Public Health Service Act (42 U.S.C. 262(c)) are each amended by striking out “Health, Education, and Welfare” each place it appears and inserting in lieu thereof “Health and Human Services”.

Section 201(y), section 506(a), section 507(a), section 702(c), section 702A, and section 706(b)(5)(C)(i) (21 U.S.C. 321(y) 356(a), 357(a), 372(c), 372a. and 376(b)(5)(C)(i)) are each amended by striking out “of Health, Education, and Welfare” each place it appears.

by striking out “801(d)” each place it occurs and inserting in lieu thereof “801(e)”; and

by striking out “clauses” and inserting in lieu thereof “paragraphs”.

by striking out “(b)(4)(B)” and inserting in lieu thereof “(b)”;

in paragraph (1), by striking out “(3)” and inserting m lieu thereof “(4)”; and

in paragraph (2), by striking out “(4)” and inserting in lieu thereof “(5)”.