TASK DEFINITION: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
PROBLEM: SECTION 1. SHORT TITLE.

This Act may be cited as the ''American Missile Protection Act of
1998''.

SEC. 2. FINDINGS.

Congress makes the following findings:
(1) The threat of weapons of mass destruction delivered by
long-range ballistic missiles is among the most serious
security issues facing the United States.
(A) In a 1994 Executive Order, President Clinton
certified, that ''I ... find that the proliferation of
nuclear, biological, and chemical weapons ('weapons of
mass destruction') and the means of delivering such
weapons, constitute an unusual and extraordinary threat
to the national security, foreign policy, and economy
of the United States, and hereby declare a national
emergency to deal with that threat.'' This state of
emergency was reaffirmed in 1995, 1996, and 1997.
(B) In 1994 the President stated, that ''there is
nothing more important to our security and the world's
stability than preventing the spread of nuclear weapons
and ballistic missiles''.
(C) Several countries hostile to the United States
have been particularly determined to acquire missiles
and weapons of mass destruction. President Clinton
observed in January of 1998, for example, that ''Saddam
Hussein has spent the better part of this decade, and
much of his nation's wealth, not on providing for the
Iraqi people, but on developing nuclear, chemical and
biological weapons and the missiles to deliver them''.
(D) In 1996, the Senate affirmed that, ''it is in
the supreme interest of the United States to defend
itself from the threat of limited ballistic missile
attack, whatever the source.''
(2) The long-range ballistic missile threat to the United
States is increasing.
(A) Several adversaries of the United States have
stated their intention to acquire intercontinental
ballistic missiles capable of attacking the United
States.
(i) Libyan leader Muammar Qaddafi has
stated, ''If they know that you have a
deterrent force capable of hitting the United
States, they would not be able to hit you. If
we had possessed a deterrent--missiles that
could reach New York--we would have hit it at
the same moment. Consequently, we should build
this force so that they and others will no
longer think about an attack.''
(ii) Abu Abbas, the head of the Palestine
Liberation Front, has stated, ''I would love to
be able to reach the American shore, but this
is very difficult. Someday an Arab country will
have ballistic missiles. Someday an Arab
country will have a nuclear bomb. It is better
for the United States and for Israel to reach
peace with the Palestinians before that day.''
(iii) Saddam Hussein has stated, ''Our
missiles cannot reach Washington. If we could
reach Washington, we would strike if the need
arose.''
(iv) Iranian actions speak for themselves.
Iran's aggressive pursuit of medium-range
ballistic missiles capable of striking Central
Europe--aided by the continuing collaboration
of outside agents--demonstrates Tehran's intent
to acquire ballistic missiles of ever-
increasing range.
(B) Over 30 non-NATO countries possess ballistic
missiles, with at least 10 of those countries
developing over 20 new types of ballistic missiles.
(C) From the end of World War II until 1980,
ballistic missiles were used in one conflict. Since
1980, thousands of ballistic missiles have been fired
in at least six different conflicts.
(D) The clear trend among countries hostile to the
United States is toward having ballistic missiles of
greater range.
(i) North Korea first acquired 300-
kilometer range Scud Bs, then developed and
deployed 500-kilometer range Scud Cs, is
currently deploying the 1000-kilometer range
No-Dong, and is developing the 2000-kilometer
range Taepo-Dong 1 and 6000-kilometer range
Taepo-Dong 2, which would be capable of
striking Alaska and Hawaii.
(ii) Iran acquired 150-kilometer range CSS-
8s, progressed through the Scud B and Scud C,
and is developing the 1300-kilometer range
Shahab-3 and 2000-kilometer range Shahab-4,
which would allow Iran to strike Central
Europe.
(iii) Iraq, in a two-year crash program,
produced a new missile, the Al-Hussein, with
twice the range of its Scud Bs.
(iv) Experience gained from extending the
range of short- and medium-range ballistic
missiles facilitates the development of
intercontinental ballistic missiles.
(E) The technical information, hardware, and other
resources necessary to build ballistic missiles are
increasingly available and accessible worldwide.
(i) Due to advances in information
technology, a vast amount of technical
information relating to ballistic missile
design, much of it formerly classified, has
become widely available and is increasingly
accessible through the Internet and other
distribution avenues.
(ii) Components, tools, and materials to
support ballistic missile development are
increasingly available in the commercial
aerospace industry.
(iii) Increasing demand for satellite-based
telecommunications is adding to the demand for
commercial Space Launch Vehicles, which employ
technology that is essentially identical to
that of intercontinental ballistic missiles. As
this increasing demand is met, the technology
and expertise associated with space launch
vehicles also proliferate.
(F) Russia and China have provided significant
technical assistance to rogue nation ballistic missile
programs, accelerating the pace of those efforts. In
June of 1997, the Director of Central Intelligence,
reporting to Congress on weapons of mass destruction-
related equipment, materials, and technology, stated
that ''China and Russia continued to be the primary
suppliers, and are key to any future efforts to stem
the flow of dual-use goods and modern weapons to
countries of concern.''
(G) Russia and China continue to engage in missile
proliferation.
(i) Despite numerous Russian assurances not
to assist Iran with its ballistic missile
program, the Deputy Assistant Secretary of
State for Nonproliferation testified to the
Senate, that ''the problem is this: there is a
disconnect between those reassurances, which we
welcome, and what we believe is actually
occurring.''
(ii) Regarding China's actions to
demonstrate the sincerity of its commitment to
nonproliferation, the Director of Central
Intelligence testified to the Senate on January
28, 1998, that, ''the jury is still out on
whether the recent changes are broad enough in
scope and whether they will hold over the
longer term. As such, Chinese activities in
this area will require continued close
watching.''
(H) The inability of the United States to defend
itself against weapons of mass destruction delivered by
long-range ballistic missile provides additional
incentive for hostile nations to develop long-range
ballistic missiles with which to threaten the United
States. Missiles are widely viewed as valuable tools
for deterring and coercing a vulnerable United States.
(3) The ability of the United States to anticipate future
ballistic missile threats is questionable.
(A) The Intelligence Community has failed to
anticipate many past technical innovations (for
example, Iraq's extended-range Al-Hussein missiles and
its development of a space launch vehicle) and outside
assistance enables rogue states to surmount traditional
technological obstacles to obtaining or developing
ballistic missiles of increasing range.
(B) In June of 1997, the Director of Central
Intelligence reported to Congress that ''many Third
World countries--with Iran being the most prominent
example--are responding to Western counter-
proliferation efforts by relying more on legitimate
commercial firms as procurement fronts and by
developing more convoluted procurement networks.''
(C) In June of 1997, the Director of Central
Intelligence stated to Congress that ''gaps and
uncertainties preclude a good projection of exactly
when 'rest of the world' countries will deploy ICBMs.''
(D) In 1997, the Director of Central Intelligence
testified that Iran would have a medium-range missile
by 2007. One year later the Director stated, ''since I
testified, Iran's success in getting technology and
materials from Russian companies, combined with recent
indigenous Iranian advances, means that it could have a
medium-range missile much sooner than I assessed last
year.'' Department of State officials have testified
that Iran could be prepared to deploy such a missile as
early as late 1998, nine years earlier than had been
predicted one year before by the Director of Central
Intelligence.
(4) The failure to prepare adequately for long-range
ballistic missile threats could have severe national security
and foreign policy consequences for the United States.
(A) An attack on the United States by a ballistic
missile equipped with a weapon of mass destruction
could inflict catastrophic death or injury to citizens
of the United States and severe damage to their
property.
(B) A rogue state's ability to threaten the United
States with an intercontinental ballistic missile may
constrain the United States' options in dealing with
regional threats to its interests, deter the United
States from taking appropriate action, or prompt allies
to question United States security guarantees, thereby
weakening alliances of the United States and the United
States' world leadership position.
(5) The United States must be prepared for rogue nations
acquiring long-range ballistic missiles armed with weapons of
mass destruction.
(A) In its resolution of ratification for the START
II Treaty, the United States Senate declared that
''because deterrence may be inadequate to protect the
United States against long-range ballistic missile
threats, missile defenses are a necessary part of new
deterrent strategies.''
(B) In September of 1994, Secretary of Defense
Perry stated that in the post-Cold War era, ''we now
have opportunity to create a new relationship based not
on MAD, not on Mutual Assured Destruction, but rather
on another acronym, MAS, or Mutual Assured Safety.''
(C) On February 12, 1997, the Under Secretary of
Defense for Policy testified to the Senate that ''I and
the administration are quite willing to acknowledge
that if we saw a rogue state, a potential proliferant,
beginning to develop a long-range ICBM capable of
reaching the United States, we would have to give very,
very serious attention to deploying a limited national
missile defense.''
(6) The United States has no defense deployed against
weapons of mass destruction delivered by long-range ballistic
missiles and no policy to deploy such a national missile
defense system.

SEC. 3. NATIONAL MISSILE DEFENSE POLICY.

It is the policy of the United States to deploy as soon as is
technologically possible an effective National Missile Defense system
capable of defending the territory of the United States against limited
ballistic missile attack (whether accidental, unauthorized, or
deliberate).

SOLUTION: American Missile Protection Act of 1998 - States as U.S. policy to deploy as soon as technologically possible an effective National Missile Defense system capable of defending U.S. territory against limited ballistic missile attack (whether accidental, unauthorized, or deliberate).

PROBLEM: S.

Section 304 of the Congressional Budget Act of 1974 is amended to
read as follows:

''permissible revisions of budget resolutions

''Sec. 304. At any time after the joint resolution on the budget
for a fiscal year has been enacted pursuant to section 301, and before
the end of such fiscal year, the two Houses and the President may enact
a joint resolution on the budget which revises or reaffirms the joint
resolution on the budget for such fiscal year most recently enacted,
and for purposes of the enforcement of the Congressional Budget Act of
1974, the chairman of the Budget Committee of the House of
Representatives or the Senate, as applicable, may adjust levels as
needed for the enforcement of the budget resolution.''.

SEC. 6. LIMITATION ON THE CONTENT OF BUDGET RESOLUTIONS.

Section 305 of the Congressional Budget Act of 1974 is amended by
adding at the end the following new subsection:
''(e) Limitation on Contents.--(1) It shall not be in order in the
House of Representatives or in the Senate to consider any joint
resolution on the budget or any amendment thereto or conference report
thereon that contains any matter referred to in paragraph (2).
''(2) Any joint resolution on the budget or any amendment thereto
or conference report thereon that contains any matter not permitted in
section 301 (a) or (b) shall not be treated in the House of
Representatives or the Senate as a budget resolution under subsection
(a) or (b) or as a conference report on a budget resolution under
subsection (c) of this section.''.

SEC. 7. DEEMING OF BUDGETARY AGGREGATES, ALLOCATIONS, AND
RECONCILIATION INSTRUCTIONS IN THE HOUSE AND SENATE UPON
VETO OF JOINT RESOLUTION ON THE BUDGET.

(a) In General.--Title III of the Congressional Budget Act of 1974
is amended by adding after section 315 the following new section:

''automatic standing order upon veto of joint resolution on the budget

''Sec. 316. For purposes of congressional enforcement under title
III and IV of this Act and the rules of the House and the Senate, the
joint resolution shall be considered as enforceable upon enactment or
15 days following presentment to the President, whichever occurs
earlier.''.
(b) Conforming Amendment.--The table of contents set forth in
section 1(b) of the Congressional Budget and Impoundment Control Act of
1974 is amended by inserting after the item relating to section 315 the
following new item:

''Sec. 316. Automatic standing order upon veto of joint resolution on
the budget.''.

SEC. 8. ADDITIONAL AMENDMENTS TO THE CONGRESSIONAL BUDGET ACT OF 1974
TO EFFECTUATE JOINT RESOLUTIONS ON THE BUDGET.

(a) Additional Amendments to the Congressional Budget and
Impoundment Control Act of 1974.--(1)(A) Sections 301, 302, 303, 304,
305, 308, 310, 311, 312, 314, 405, and 904 of the Congressional Budget
Act of 1974 (2 U.S.C. 621 et seq.) are amended by striking
''concurrent'' each place it appears and inserting ''joint''.
(B)(i) Sections 302(d), 302(g), 308(a)(1)(A), and 310(d)(1) of the
Congressional Budget Act of 1974 are amended by striking ''most
recently agreed to concurrent resolution on the budget'' each place it
occurs and inserting ''most recently enacted joint resolution on the
budget''.
(ii) The section heading of section 301 of such Act is amended by
striking ''annual adoption of concurrent resolution'' and inserting
''joint resolutions''.
(C) Sections 302, 303, 304, 310, and 311 of the Congressional
Budget Act of 1974 are amended by striking ''agreed to'' each place it
appears and by inserting ''enacted''.
(2) The table of contents set forth in section 1(b) of the
Congressional Budget and Impoundment Control Act of 1974 is amended--
(A) in the item relating to section 301, by striking
''Annual adoption of concurrent resolution'' and inserting
''Joint resolutions''; and
(B) by striking ''concurrent'' and inserting ''joint'' in
the item relating to section 305.
(b) Conforming Amendment.--Any side heading within any section of
title III of the Congressional Budget and Impoundment Control Act of
1974 is amended by striking ''Concurrent'' and inserting ''Joint'' and
any center heading in any section of that title is amended by striking
''concurrent'' and inserting ''joint''.

SEC. 9. AMENDMENTS TO THE RULES OF THE HOUSE OF REPRESENTATIVES TO
EFFECTUATE JOINT BUDGET RESOLUTIONS.

Clauses 1(d)(1), 4(a)(4), 4(b)(2), 4(f)(1)(A), and 4(f)(2) of rule
X, clause 10 of rule XVIII, clause 10 of rule XX, and clauses 7 and 10
of rule XXI of the Rules of the House of Representatives are amended by
striking ''concurrent'' each place it appears and inserting ''joint''.

SEC. 10. CONFORMING AMENDMENTS TO THE BALANCED BUDGET AND EMERGENCY
DEFICIT CONTROL ACT OF 1985.

Section 258C(b)(1) of the Balanced Budget and Emergency Deficit
Control Act of 1985 (2 U.S.C. 907d(b)(1)) is amended by striking
''concurrent'' and inserting ''joint''.

SOLUTION: Legally Binding Budget Act of 2013 - Amends the Congressional Budget Act of 1974 (CBA) to require joint budget resolutions signed by the President instead of the concurrent resolutions now required (which do not have to be signed by the President). Revises accordingly the congressional procedures for considering joint budget resolutions. Prohibits the consideration of budget-related legislation before the joint budget resolution becomes law. Requires the joint budget resolution to set forth appropriate levels for the fiscal year beginning on October 1 of such year and for at least each of the four ensuing fiscal years for the public debt limit for display purposes only. Permits revisions of joint budget resolutions already enacted. Makes a conforming amendment to the Congressional Budget and Impoundment Control Act of 1974. Makes it out of order in both chambers to consider any joint budget resolution, amendment, or conference report that contains certain matter prohibited by the CBA, particularly inclusion in the surplus or deficit totals of any outlays and revenue totals of the Old Age, Survivors, and Disability Insurance (OASDI) program under title II of the Social Security Act. Considers the joint budget resolution as enforceable upon enactment or 15 days following presentment to the President, whichever occurs earlier. (Thus creates an automatic standing order upon a presidential veto of a joint budget resolution.) Makes conforming amendments to: (1) the Rules of the House of Representatives, and (2) the Balanced Budget and Emergency Deficit Control Act of 1985 (Gramm-Rudman-Hollings Act).

PROBLEM: SECTION 1. SHORT TITLE AND REFERENCE.

(a) Short Title.--This Act may be cited as the ''Medical
Technology, Public Health, and Innovation Act of 1997''.
(b) Reference.--Whenever in this Act an amendment or repeal is
expressed in terms of an amendment to, or a repeal of, a section or
other provision, the reference shall be considered to be made to a
section or other provision of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321 et seq.).

SEC. 2. FINDINGS; MISSIONS STATEMENT.

(a) Findings.--The Congress finds the following:
(1) While the United States appropriately puts a top
priority on the regulation of medical technologies to ensure
the safety and efficacy of medical technologies that are
introduced into the marketplace, the administration of such
regulatory effort is causing the United States to lose its
leadership role in producing innovative, top-quality medical
devices.
(2) One of the key components of the medical device
regulatory process that contributes to the United States losing
its leadership role in medical device development is the
inordinate amount of time it takes for medical technologies to
be reviewed by the Food and Drug Administration.
(3) The most important result of the United States losing
its leadership role is that patients in the United States do
not have access to new medical technology in a timely manner.
(4) Delayed patient access to new medical technology
results in lost opportunities to save lives, to reduce
hospitalization and recovery time, and to improve the quality
of life of patients.
(5) The economic benefits that the United States medical
device industry, which is composed principally of smaller
companies, has provided through growth in jobs and global trade
are threatened by the slow and unpredictable regulatory process
at the Food and Drug Administration.
(6) The pace and predictability of the medical device
regulatory process are in part responsible for the increasing
tendency of United States medical device companies to shift
research, product development, and manufacturing offshore, at
the expense of American jobs, patients, and leading edge
clinical research.
(b) Mission Statement.--This legislation seeks to improve the
timeliness, effectiveness, and predictability of the medical device
approval process for the benefit of United States patients and the
United States economy by--
(1) providing for the use of nationally and internationally
recognized performance standards to assist the Food and Drug
Administration in determining the safety and effectiveness of
medical devices;
(2) facilitating communication between medical device
companies and the Food and Drug Administration;
(3) targeting the use of Food and Drug Administration
resources on medical devices that are likely to have serious
adverse health consequences; and
(4) requiring the Food and Drug Administration to determine
the least costly, most efficient approach to reasonably
assuring the safety and effectiveness of devices.

SEC. 3. DEVICE PERFORMANCE STANDARDS.

(a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is amended
by adding at the end the following:

''recognition of a performance standard

''(c)(1)(A) The Secretary may, through publication in the Federal
Register, issue notices identifying and listing nationally and
internationally recognized performance standards for which persons may
provide a certification of a device's conformity under paragraph (3) in
order to meet the premarket submission requirements or other
requirements under the Act to which the standards are applicable.
''(B) Any person may elect to utilize data other than data required
by the standards described in subparagraph (A) to meet any requirement
under the Act to which the standards are applicable.
''(2) The Secretary may remove from the list of standards described
in paragraph (1) a standard that the Secretary determines is no longer
appropriate for making determinations with respect to the regulation of
devices.
''(3)(A) A person may provide a certification that a device
conforms to an applicable standard listed under paragraph (1) to meet
the requirements described in paragraph (1) and the Secretary shall
accept such certification.
''(B) The Secretary may, at any time, request a person who submits
a certification described in subparagraph (A) to submit the data or
information that the person relied on in making the certification.
''(C) A person who submits a certification described in
subparagraph (A) shall maintain the data and information upon which the
certification was made for a period of 2 years after the submission of
the certification or a time equal to the expected design life of a
device, whichever is longer.''.
(b) Section 301.--Section 301 (21 U.S.C. 331) is amended by adding
at the end the following:
''(x) The falsification of a certification submitted under section
514(c)(3) or the failure or refusal to provide data or information
requested by the Secretary under such section.''.
(c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is amended by
striking ''established'' and inserting ''established or listed''.

SEC. 4. PREMARKET APPROVAL.

(a) Application.--Section 515(c) (21 U.S.C. 360e(c)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (F), by striking ''; and'' and
inserting a semicolon;
(B) in subparagraph (G), by striking ''require.''
and inserting ''require; and''; and
(C) by adding at the end the following:
''(H) an identifying reference to any performance standard
listed under section 514(c) that is applicable to such
device.''.
(2) by adding at the end the following:
''(3) The Secretary shall accept historical clinical data as a
control for use in determining whether there is a reasonable assurance
of safety and effectiveness of a device in a case in which the effects
of the progression of a disease are clearly defined and well
understood.
''(4) The Secretary may not require the sponsor of an application
to conduct clinical trials for a device using randomized controls
unless the controls--
''(A) are necessary;
''(B) are scientifically and ethically feasible; and
''(C) other less burdensome and controls, such as
historical controls, are not available to permit a
determination of a reasonable assurance of safety and
effectiveness.''.
(b) Action on Application.--Section 515(d) (21 U.S.C. 360e(d)) is
amended--
(1) in paragraph (1)(A)--
(A) by striking ''paragraph (2) of this
subsection'' each place it appears and inserting
''paragraph (8)''; and
(B) by adding at the end the following flush
paragraph:
''In making a determination to approve or deny an application, the
Secretary shall rely on the conditions of use proposed in the labeling
of device as the basis for determining whether or not there is a
reasonable assurance of safety and effectiveness. If, based on a fair
evaluation of all material facts, the proposed labeling of the device
is neither false nor misleading in any particular, the Secretary shall
not consider conditions of use not included in such labeling in making
the determination.'';
(2) by redesignating paragraphs (2) and (3) as paragraphs
(8) and (9), respectively; and
(3) by inserting after paragraph (1) the following:
''(2) Each application received under subsection (c) shall be
reviewed in a manner to achieve final action within the 180-day period
described in subparagraph (A), and the 180-day period may not be
altered for any reason without the written consent of an applicant.
''(3)(A) Not later than 100 days after the receipt of an
application that has been filed by the Secretary because the
application satisfies the content requirements of subsection (c)(1),
the Secretary shall meet with the applicant and disclose each
deficiency relating to the application that would preclude approval of
the application under paragraph (1).
''(B) The applicant shall have the right to be informed in writing
with respect to the information communicated to the applicant during
the meeting.
''(4) To permit better treatment or better diagnoses of life-
threatening or irreversibly debilitating diseases or conditions, the
Secretary shall expedite the review for devices--
''(A) representing breakthrough technologies;
''(B) offering significant advantages over existing
approved alternatives; or
''(C) for which accelerated availability is in the best
interest of the public health.
''(5) The Secretary shall complete the review of all supplemental
applicants to an application approved under paragraph (1) that do not
contain clinical data within 90 days after the receipt of a
supplemental that has been accepted for filing.''
''(6)(A) A supplemental application shall be required for any
change to a device subject to an approved application under this
subsection if the change affects safety or effectiveness, unless the
change is a modification in a manufacturing procedures or method of
manufacturing and the holder of an approved application submits a
notice to the Secretary that describes the change and informs the
Secretary that the change has been made under the requirements of
section 520(f).
''(B)(i) In reviewing a supplement to an approved application for
an incremental change to the design of a device that affects safety or
effectiveness, the Secretary shall approve the supplement if--
''(I) nonclinical data demonstrate that a design
modification creates the intended additional capacity,
function, or performance of the device; and
''(II) clinical data from the approved application and any
supplements to the approved application provide a reasonable
assurance of safety and effectiveness.
''(ii) The Secretary may require, when necessary, additional
clinical data to evaluate the design modification to provide a
reasonable assurance of safety and effectiveness.
''(7) Any representation in promotional materials for a device
subject to an approved application under this subsection shall not be
subject to premarket approval under this section, unless such
representations establish new conditions of use. Any representations
made in promotional materials for devices subject to an approved
application shall be supported by appropriate data or information that
can substantiate the representations at the time such representations
are made.''.
(c) Withdrawal or Temporary Suspension of Approval of
Application.--Section 5155(e)(1) (21 U.S.C. 360e(1)) is amended in
subparagraph (G) by inserting after the word ''effect'' the words ''or
listed.''

SEC. 5. PREMARKET NOTIFICATION.

(a) Exemption of Certain Devices.--Section 510 (21 U.S.C. 360) is
amended--
(1) in subsection (k), by striking ''intended for human
use'' and inserting ''intended for human use (except a device
that is classified into class I under section 513 or 520 or a
device that is classified into class II under section 513 or
520, and is exempt from the requirements of this subsection
under subsection (l))'';
(2) by adding at the end of subsection (k) (as amended by
paragraph (1)) the following flush sentence:
''The Secretary shall review the notification required by this
subsection and make a determination under section 513(f)(1)(A) within
90 days after receiving the notification.''; and
(3) by adding at the end the following:
''(1)(A) Within 30 days after the date of enactment of this
subsection, the Secretary shall develop and publish in the Federal
Register a list of each type of class II device that does not require a
report under subsection (k) to provide reasonable assurance of safety
and effectiveness. Each type of class II device identified by the
Secretary not to require the report shall be exempt from the
requirement to file a report under subsection (k) as of the date of the
publication of the list in the Federal Register.
''(B) Beginning on the date that is 1 day after the date of the
publication of a list under this subsection, any person may petition
the Secretary to exempt a type of class II device from the requirement
of subsection (k). The Secretary shall respond to the petition within
120 days after the receipt of the petition and determine whether or not
to grant the petition in whole or in part.''.
(b) Special Rule Relating to Exemption of Class I Devices From
510(k) Notifications.--The exemption of a class I device from the
notification requirement of section 510(k) shall not apply to a class I
device that is life sustaining or life saving or that is intended to be
implanted into the human body.

SEC. 6. INVESTIGATIONAL DEVICE EXEMPTION.

(a) Regulations.--Section 520(g) (21 U.S.C. 360j(g)) is amended--
(1) by redesignating paragraphs (4) and (5) as paragraphs
(5) and (6), respectively; and
(2) by inserting after paragraph (3) the following:
''(4) The Secretary shall, within 120 days after the date of
enactment of this paragraph, by regulation, amending the content of
part 812 of title 21 of the Code of Federal Regulations, amend the
procedures with respect to the approval of clinical studies under this
subsection as follows:
''(A) The Secretary shall permit the sponsor of an
investigation to meet with the Secretary prior to the
submission of an application to develop a protocol for a
clinical study subject to the regulation and require that the
protocol be agreed upon in writing by the sponsor and the
Secretary.
''(B)(i) The Secretary shall permit developmental changes
to devices in response to information gathered during the
course of an investigation without requiring an additional
approval of an application for an investigational device
exemption, or the approval of a supplement to the application,
if the changes meet the following requirements:
''(I) The changes do not constitute a significant
change in the design of the product or a significant
change in basic principles of operation.
''(II) The changes do not adversely affect patient
safety.
''(ii) The Secretary shall require that each such change
shall be documented with information describing the change and
the basis of the sponsor of application for concluding that the
change does not constitute a significant change in design or
operating principles, and that the change does not adversely
affect patient safety.''.
(b) Conforming Amendments.--Section 517(a)(7) (21 U.S.C.
360g(a)(7)) is amended--
(1) by striking ''section 520(g)(4)'' and inserting
''section 520(g)(5)''; and
(2) by striking ''section 520(g)(5)'' and inserting
''section 520(g)(6)''.

SEC. 7 PRODUCT REVIEW.

Section 513 (21 U.S.C. 360c) is amended by--
(1) in subsection (a)(3)(A)--
(A) by striking ''including clinical investigations
where appropriate'' and inserting ''including 1 or more
clinical investigations where appropriate'';
(B) by adding at the end the following: ''When
evaluating the type and amount of data necessary to
find a reasonable assurance of device effectiveness for
an approval under section 515, the Secretary shall
consider the extent to which reliance on postmarket
controls may contribute to such assurance and expedite
effectiveness determinations without increasing
regulatory burdens on persons who submit applications
under section 515(c).'';
(2) in subsection (a)(3), by adding at the end the
following:
''(C)(i) The Secretary upon the request of any person intending to
submit an application under section 515 shall meet with the person to
determine the type of valid scientific evidence within the meaning of
subparagraphs (A) and (B) that will be necessary to demonstrate the
effectiveness of a device for the conditions of use proposed by such
person to support an approval of an application.
''(ii) Within 30 days after such meeting, the Secretary shall
specify in writing the type of valid scientific evidence that will
provide a reasonable assurance that a device is effective under the
conditions of use proposed by the person.
''(iii) Any clinical data, including 1 or more well-controlled
investigations, specified by the Secretary for demonstrating a
reasonable assurance of device effectiveness shall reflect the
Secretary's determination that such data are necessary to establish
device effectiveness and that no other less burdensome means of
evaluating device effectiveness are available which would have a
reasonable likelihood of resulting in an approval.
''(2) The determination of the Secretary with respect to the
specification of the valid scientific evidence under clause (ii) shall
be binding upon the Secretary, unless such determination by the
Secretary would be contrary to the public health''; and
(3) in subsection (i), by adding at the end the following:
''(C) To facilitate reviews of reports submitted to the Secretary
under section 510(k), the Secretary shall consider the extent to which
reliance on postmarket controls may expedite the classification of
devices under subsection (f)(1).
''(D) Whenever the Secretary requests information to demonstrate
that devices with differing technological characteristics are
substantially equivalent, the Secretary shall only request information
that is necessary to making substantial equivalence determinations. In
making such requests, the Secretary shall consider the least burdensome
means of demonstrating substantial equivalence and request information
accordingly.
''(E) Any determinations of substantial equivalence by the
Secretary shall be based upon the intended uses proposed in labeling
submitted in a report under section 510(k).
''(F) Any representations made in promotional materials for devices
shall not require a report under section 510(k), unless such
representations establish new intended uses for a legally marketed
device.''.

SOLUTION:
Medical Technology, Public Health, and Innovation Act of 1997 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to authorize the Secretary of Health and Human Services to identify and list nationally and internationally recognized performance standards for which persons may self-certify a device's conformity in order to meet FDCA requirements. Allows use of data other than that required by the standards to meet any FDCA requirement. Adds to the list of prohibited acts certification falsification or the failure or refusal to provide the data or information relied on in the certification.
(Sec. 4) Requires that premarket approval applications include an identifying reference to any such performance standard. Directs the Secretary to accept historical clinical data as a control for use in determining safety and effectiveness when a disease's progression is clearly defined and well understood. Limits requiring clinical trials using randomized controls. Modifies requirements regarding action on premarket approval applications.
(Sec. 5) Exempts from premarket notification requirements certain class I and class II devices. Directs the Secretary to develop and publish a list of each type of class II device not requiring premarket notification. Allows petitioning for exemption of a class II type from the notification requirement.
(Sec. 6) Changes clinical study approval procedures, allowing: (1) the investigation sponsor to meet with the Secretary before application submission to develop a protocol; and (2) device developmental changes during an investigation without requiring an additional approval or an application supplement, if certain requirements are met.
(Sec. 7) Allows device effectiveness to be determined on the basis of one or more clinical investigations (currently, by well-controlled investigations). Requires the Secretary: (1) to consider the extent to which postmarket controls may contribute to the assurance of effectiveness and expedite effectiveness determinations without increasing regulatory burdens; (2) on request, to meet with an intended applicant to determine the type of effectiveness evidence that will be necessary; (3) to consider the extent to which postmarket controls may expedite device classification; (4) when requesting information demonstrating substantial equivalence, to only request information necessary to make substantial equivalence determinations; and (5) base substantial equivalence determinations on the intended uses in submitted labeling.