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such standards to demonstrate a reasonable assurance of
device safety or effectiveness or compliance with require-
ments under the Act.
‘‘(2) The Secretary in lieu of receiving data dem-
onstrating conformance to standards referenced in para-
graph (1) shall accept certifications from regulated per-
sons that devices conform with each standard identified
in each such certification.
‘‘(d) The Secretary shall not rely upon informal agen-
cy statements, including guidance documents, policy state-
ments, points to consider documents, or any other state-
ments intended for a similar purpose, to require any ac-
tion be taken to satisfy a requirement under the Act, un-
less such statement is first subject to the rulemaking pro-
cedure set forth in section 5 U.S.C. e 553.’’.
SEC. 16. EXPORT OF NEW DRUGS AND DEVICES.
Section 801(e) (21 U.S.C. 381(e)) is amended—
(1) in paragraph (1), by inserting after ‘‘under
this Act’’ the following: ‘‘or in violation of section
505 or section 351 of the Public Health Service
Act’’,
(2) in paragraph (1), by striking the last sen-
tence, and
(3) by amending paragraph (2) to read as fol-
lows:
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‘‘(2) Paragraph (1) does not apply to the export of—
‘‘(A) any device—
‘‘(i) which does not comply with an appli-
cable requirement under section 514 or 515,
‘‘(ii) which under section 520(g) is exempt
from either such section, or
‘‘(iii) which is a banned device under sec-
tion 516, or
‘‘(B) any drug (including a biological product)
which does not comply with an applicable require-
ment under section 505 or 512 or section 351 of the
Public Health Service Act,
unless the device or drug is in compliance with the require-
ments of paragraph (1). In the case of a device or drug
for which an export notice is required under this para-
graph, the Secretary may prohibit the export of such de-
vice or drug if the Secretary determines that the possibil-
ity of the reimportation of the device or drug into the
United States presents an imminent hazard to the public
health and safety of the United States and the only means
of limiting the hazard is to prohibit the export of the de-
vice or drug.’’.
SEC. 17. RECLASSIFICATION OF CERTAIN DEVICES.
Section 515 (21 U.S.C. 360e) is amended by adding
at the end the following new subsection:
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‘‘RECLASSIFICATION
‘‘(j) The Secretary shall, within 18 months of the
date of enactment of this subsection, publish in the Fed-
eral Register a proposed regulation reclassifying all de-
vices identified in subsection (i)(2) into class II, unless
the Secretary has already published a proposed regulation
required under subsection (i) for each such device. The
Secretary shall provide 60 days for comment on the pro-
posed regulation, and shall publish a final regulation in
the Federal Register within 60 days after the last day for
comment reclassifying into class II each such device not
included in a regulation required under subsection (i), or
maintaining, where appropriate, the original classification
of such devices.’’.
SEC. 18. TRACKING.
(a) Section 519(e) is amended to read as follows:
‘‘(e) Every person who registers under section 510
and is engaged in the manufacture of a class II or class
III device the failure of which would be reasonably likely
to have life threatening or permanently debilitating health
consequences attributable to the device and which is a per-
manently implantable device, or a life sustaining or life
supporting device used outside a device user facility, or
may designate, shall adopt a method of device tracking.
Manufacturers subject to tracking may satisfy the require-
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ments of this subsection by relying exclusively on social
security numbers as a method of device tracking.’’.
(b) The Secretary of Health and Human Services
shall, within 12 months of the date of the enactment of
this Act, revise regulations appearing in part 821 of title
21 of the Code of Federal Regulations, to conform to sec-
tion 519 of the Federal Food, Drug, and Cosmetic Act
as amended by subsection (a).
(c) 
Section 
205(c)(2)(C)(vii) 
(42 
U.S.C. 
e
405(c)(2)(C)(viii)) of the Social Security Act is amended
by redesignating subclauses (II), (III), and (IV) as (III),
(IV), and (V), and inserting after subclause (I) the follow-
ing new subclause:
‘‘(II) Section 519(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360i(e)) is exempted from sub-
clause (I). Social Security account numbers and related
records obtained or maintained by authorized persons
shall be available for use under section 519(e) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e))
for purposes of device tracking. The requirements under
section 7(b) of the Privacy Act of 1974 (Public Law No.
93–579, 88 Stat. 1896), shall not apply to any Federal,
State, or local government agency requesting a person to
disclose his/her social security account number for pur-
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poses of device tracking under section 519(e) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)).’’.
SEC. 19. POSTMARKET SURVEILLANCE.
Section 522 (21 U.S.C. 360l) is amended to read as
follows:
‘‘POSTMARKET SURVEILLANCE
‘‘SEC. 522. (a) The Secretary may require a manu-
facturer to conduct postmarket surveillance for any device
of the manufacturer first introduced or delivered for intro-
duction into interstate commerce after January 1, 1991,
that is a class III device the failure of which would be
reasonably likely to have life threatening or permanently
debilitating consequences attributable to the device and
which is (1) a permanently implantable device, or (2) a
life sustaining or life supporting device used outside a de-
vice user facility.
‘‘(b) Each manufacturer required to conduct a sur-
veillance of a device shall, within 30 days of receiving no-
tice from the Secretary that the manufacturer is required
under this section to conduct such surveillance and sub-
mit, for the approval of the Secretary, a protocol for the
required surveillance. The Secretary, within 60 days of the
receipt of such protocol, shall determine if the principal
investigator proposed to be used in the surveillance has
sufficient qualifications and experience to conduct such
surveillance and if such protocol will result in collection
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of useful data or other information necessary to protect
the public health and to provide safety and effectiveness
information for the device. The Secretary may not approve
such a protocol until it has been reviewed by an appro-
priately qualified scientific and technical review committee
established by the Secretary.’’.
SEC. 20. MISCELLANEOUS.
(a) Chapter III of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355 et seq.) is amended by adding
at the end thereof the following new sections:
‘‘DISSEMINATION OF TREATMENT INFORMATION ON
DRUGS AND BIOLOGICAL PRODUCTS
‘‘SEC. 311. (a)(1) Notwithstanding sections 301(d),
502(f), 505, and 507 and section 351 of the Public Health
Service Act (42 U.S.C. 262), and subject to the require-
ments of paragraph (2) and subsection (b), a person may
disseminate to any person that is a health care practi-
tioner or other provider of health care goods or services,
a pharmacy benefit manager, a health maintenance orga-
nization or other managed health care organization, or a
health care insurer or governmental agency, written infor-
mation, or an oral or written summary of the written in-
formation, concerning—
‘‘(A) a treatment use for an investigational new
drug or an investigational biological product ap-
proved by the Secretary for such treatment use; or
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‘‘(C) the information relates to a use that is
recognized under Federal law for purposes of third-
party coverage or reimbursement, and—
‘‘(i) the text of the information has been
approved by an organization referred to in such
Federal law; or
‘‘(ii) the information is part of a disease
management program or treatment guideline
with respect to such use; or
‘‘(D) the information is an accurate and truth-
ful summary of the information described in sub-
paragraph (A), (B), or (C).
‘‘(b) In order to afford a full and fair evaluation of
the information described in subsection (a), a person dis-
seminating the information shall include a statement that
discloses—
‘‘(1) if applicable, that the use of a new drug
or biological product described in subparagraph (A)
or (B) of subsection (a)(1) and the information with
respect to the use have not been approved by the
Food and Drug Administration;
‘‘(2) if applicable, that the information is being
disseminated at the expense of the sponsor of the
drug or biological product;
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‘‘(3) if applicable, that one or more authors of
the information being disseminated are employees of
or consultants to the sponsor of the drug or biologi-
cal product; and
‘‘(4) the official labeling for the drug and bio-
logical product, or in the case of a treatment use of
an investigational drug or biological product, the in-
vestigator brochure and all updates thereof.
‘‘(c) As used in this section, the term ‘expense’ in-
cludes financial, in-kind, and other contributions provided
for the purpose of disseminating the information described
in subsection (a).
‘‘(d) In the case of a professional disagreement be-
tween the Secretary and other qualified experts with re-
spect to the application of section 502(a), the Secretary
may not use section 502 to prohibit the dissemination of
information in the types of circumstances and under the
conditions set forth in subsections (a) and (b).
‘‘DISSEMINATION OF INFORMATION ON DEVICES
SEC. 312. (a) Notwithstanding sections 301, 501(f),
501(i), 502(a), 502(f), and 502(o), or any other provision
of law, and subject to subsections (b) and (c), a person
may disseminate to any person that is a health care practi-
tioner or other provider of health care goods or services,
a pharmacy benefit manager, a health maintenance orga-
nization or other managed health care organization, or a
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health care insurer or governmental agency, written or
oral information (including information exchanged at sci-
entific and educational meetings, workshops, or dem-
onstrations) relating to a use, whether or not the use is
described in the official labeling, of a device produced by
a manufacturer registered pursuant to section 510.
‘‘(b)(1) To the extent practicable, the requirement
with respect to a statement of disclosure under subsection
(b) of section 311 shall apply to the dissemination of writ-
ten and oral information under this section, except that
this paragraph shall not apply to the dissemination of
written or oral information with respect to the intended
use described in the labeling of a device.
‘‘(2) A person may disseminate information under
subsection (a) only if—
‘‘(A) the information is an unabridged—
‘‘(i) reprint or copy of a peer-reviewed arti-
cle from a scientific or medical journal that is
published by an organization that is independ-
ent of the medical device industry; or
‘‘(ii) chapter, authored by an expert or ex-
perts in the medical specialty to which the use
relates, from a recognized reference textbook
that is published by an organization that is
independent of the medical device industry;
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‘‘(B) the information has been approved by a
continuing medical education accrediting agency that
is independent of the medical device industry as part
of a scientific or medical educational program ap-
proved by such agency;
‘‘(C) the information relates to a use that is
recognized under Federal law for purposes of third-
party reimbursement, and—
‘‘(i) the text of the information has been
approved by an organization referred to in such
Federal law; or
‘‘(ii) the information is part of a disease
management program or treatment guideline
with respect to such use; or
‘‘(D) the oral or written information is—
‘‘(i) part of an exchange of information
solely among health care practitioners, health
care reimbursement officials, and the industry;
‘‘(ii) exchanged for educational or scientific
purposes; and
‘‘(iii) presented at continuing medical edu-
cation programs, seminars, workshops, or dem-
onstrations.
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‘‘(3) The requirements under subsection (a)(1)(A)
and (B) of section 311 shall not apply with respect to de-
vices.
‘‘(c) Notwithstanding section 502(a), 502(f), 502(o),
or any other provision of law, the written or oral dissemi-
nation of information relating to a new use of a device,
in accordance with this section, shall not be construed by
the Secretary as evidence of a new intended use of the
device that is different from the intended use of the device
set forth on the official labeling of the device. Such dis-
semination shall not be considered by the Secretary as la-
beling, adulteration, or misbranding of the device.’’.
(b) Section 519 (21 U.S.C. 360i) is amended to read
as follows:
‘‘RECORDS AND REPORTS ON DEVICES
‘‘SEC. 519. (a) Every person who is a manufacturer
or importer, of a device intended for human use shall es-
tablish and maintain such records, make such reports, and
provide such information, as the Secretary may by regula-
tion reasonably require to assure that such device is not
adulterated or misbranded and to otherwise assure its
safety and effectiveness. Regulations prescribed under the
preceding sentence—
‘‘(1) shall require a device manufacturer or im-
porter to report to the Secretary whenever the man-
ufacturer or importer receives or otherwise becomes