FDA2 — Health Hippo

fda2

FILE s830.
enr –S.830–S.830

An Act To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes.

This Act may be cited as the ‘Food and Drug Administration Modernization Act of 1997’

TITLE II–IMPROVING
REGULATION OF DEVICES

SEC. 201. Investigational device exemptions

SEC. 202. Special review for certain devices

SEC. 203. Expanding humanitarian use of
devices

SEC. 204. Device standards

SEC. 205. Scope of review; collaborative
determinations of device data requirements

SEC. 206. Premarket notification

SEC. 207. Evaluation of automatic class III
designation

SEC. 208. Classification panels

SEC. 209. Certainty of review timeframes;
collaborative review process

SEC. 210. Accreditation of persons for
review of premarket notification reports

SEC. 211. Device tracking

SEC. 212. Postmarket surveillance

SEC. 213. Reports

SEC. 214. Practice of medicine

SEC. 215. Noninvasive blood glucose meter

SEC. 216. Use of data relating to premarket
approval; product development protocol

SEC. 217. Clarification of the number of
required clinical investigations for approval

SEC. 201. INVESTIGATIONAL DEVICE EXEMPTIONS

(a) IN GENERAL- Section 520(g) (21 U.S.C. 360j(g)) is amended by
adding at the end the following: ‘(6)(A) Not later than 1 year after
the date of the enactment of the Food and Drug Administration
Modernization Act of 1997, the Secretary shall by regulation
establish, with respect to a device for which an exemption under this
subsection is in effect, procedures and conditions that, without
requiring an additional approval of an application for an exemption
or the approval of a supplement to such an application, permit–

‘(i) developmental changes in the device (including manufacturing
changes) that do not constitute a significant change in design or in
basic principles of operation and that are made in response to
information gathered during the course of an investigation; and

‘(ii) changes or modifications to clinical protocols that do not
affect– ‘(I) the validity of data or information resulting from the
completion of an approved protocol, or the relationship of likely
patient risk to benefit relied upon to approve a protocol; ‘(II) the
scientific soundness of an investigational plan submitted under
paragraph (3)(A); or ‘(III) the rights, safety, or welfare of the
human subjects involved in the investigation.

‘(B) Regulations under subparagraph (A) shall provide that a
change or modification described in such subparagraph may be made
if–

‘(i) the sponsor of the investigation determines, on the basis of
credible information (as defined by the Secretary) that the
applicable conditions under subparagraph (A) are met; and

‘(ii) the sponsor submits to the Secretary, not later than 5 days
after making the change or modification, a notice of the change or
modification.

‘(7)(A) In the case of a person intending to investigate the
safety or effectiveness of a class III device or any implantable
device, the Secretary shall ensure that the person has an
opportunity, prior to submitting an application to the Secretary or
to an institutional review committee, to submit to the Secretary, for
review, an investigational plan (including a clinical protocol). If
the applicant submits a written request for a meeting with the
Secretary regarding such review, the Secretary shall, not later than
30 days after receiving the request, meet with the applicant for the
purpose of reaching agreement regarding the investigational plan
(including a clinical protocol). The written request shall include a
detailed description of the device, a detailed description of the
proposed conditions of use of the device, a proposed plan (including
a clinical protocol) for determining whether there is a reasonable
assurance of effectiveness, and, if available, information regarding
the expected performance from the device.

‘(B) Any agreement regarding the parameters of an investigational
plan (including a clinical protocol) that is reached between the
Secretary and a sponsor or applicant shall be reduced to writing and
made part of the administrative record by the Secretary. Any such
agreement shall not be changed, except–

‘(i) with the written agreement of the sponsor or applicant; or

‘(ii) pursuant to a decision, made in accordance with subparagraph
(C) by the director of the office in which the device involved is
reviewed, that a substantial scientific issue essential to
determining the safety or effectiveness of the device involved has
been identified.

‘(C) A decision under subparagraph (B)(ii) by the director shall
be in writing, and may be made only after the Secretary has provided
to the sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant are present and at which the
director documents the scientific issue involved.’

(b) ACTION ON APPLICATION- Section 515(d)(1)(B) (21 U.S.C

360e(d)(1)(B)) is amended by adding at the end the following:
‘(iii) The Secretary shall accept and review statistically valid and
reliable data and any other information from investigations conducted
under the authority of regulations required by section 520(g) to make
a determination of whether there is a reasonable assurance of safety
and effectiveness of a device subject to a pending application under
this section if–

‘(I) the data or information is derived from investigations of an
earlier version of the device, the device has been modified during or
after the investigations (but prior to submission of an application
under subsection (c)) and such a modification of the device does not
constitute a significant change in the design or in the basic
principles of operation of the device that would invalidate the data
or information; or

‘(II) the data or information relates to a device approved under
this section, is available for use under this Act, and is relevant to
the design and intended use of the device for which the application
is pending.’

SEC. 202. SPECIAL REVIEW FOR CERTAIN DEVICES

Section 515(d) (21 U.S.C. 360e(d)) is amended–

(1) by redesignating paragraph (3) as paragraph (4); and

(2) by adding at the end the following: ‘(5) In order to provide
for more effective treatment or diagnosis of life-threatening or
irreversibly debilitating human diseases or conditions, the Secretary
shall provide review priority for devices–

‘(A) representing breakthrough technologies,

‘(B) for which no approved alternatives exist,

‘(C) which offer significant advantages over existing approved
alternatives, or

‘(D) the availability of which is in the best interest of the
patients.’

SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES

Section 520(m) (21 U.S.C. 360j(m)) is amended–

(1) in paragraph (2), by adding after and below subparagraph (C)
the following sentences: ‘The request shall be in the form of an
application submitted to the Secretary. Not later than 75 days after
the date of the receipt of the application, the Secretary shall issue
an order approving or denying the application.’;

(2) in paragraph (4)– (A) in subparagraph (B), by inserting after
‘(2)(A)’ the following: ‘, unless a physician determines in an
emergency situation that approval from a local institutional review
committee can not be obtained in time to prevent serious harm or
death to a patient’; and (B) by adding after and below subparagraph
(B) the following: ‘In a case described in subparagraph (B) in which
a physician uses a device without an approval from an institutional
review committee, the physician shall, after the use of the device,
notify the chairperson of the local institutional review committee of
such use. Such notification shall include the identification of the
patient involved, the date on which the device was used, and the
reason for the use.’;

(3) by amending paragraph (5) to read as follows: ‘(5) The
Secretary may require a person granted an exemption under paragraph
(2) to demonstrate continued compliance with the requirements of this
subsection if the Secretary believes such demonstration to be
necessary to protect the public health or if the Secretary has reason
to believe that the criteria for the exemption are no longer met.’;
and

(4) by amending paragraph (6) to read as follows: ‘(6) The
Secretary may suspend or withdraw an exemption from the effectiveness
requirements of sections 514 and 515 for a humanitarian device only
after providing notice and an opportunity for an informal hearing.’

SEC. 204. DEVICE STANDARDS

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

‘RECOGNITION OF A STANDARD ‘(c)(1)(A) In addition to establishing
a performance standard under this section, the Secretary shall, by
publication in the Federal Register, recognize all or part of an
appropriate standard established by a nationally or internationally
recognized standard development organization for which a person may
submit a declaration of conformity in order to meet a premarket
submission requirement or other requirement under this Act to which
such standard is applicable.

‘(B) If a person elects to use a standard recognized by the
Secretary under subparagraph (A) to meet the requirements described
in such subparagraph, the person shall provide a declaration of
conformity to the Secretary that certifies that the device is in
conformity with such standard. A person may elect to use data, or
information, other than data required by a standard recognized under
subparagraph (A) to meet any requirement regarding devices under this
Act.

‘(2) The Secretary may withdraw such recognition of a standard
through publication of a notice in the Federal Register if the
Secretary determines that the standard is no longer appropriate for
meeting a requirement regarding devices under this Act.

‘(3)(A) Subject to subparagraph (B), the Secretary shall accept a
declaration of conformity that a device is in conformity with a
standard recognized under paragraph (1) unless the Secretary finds–

‘(i) that the data or information submitted to support such
declaration does not demonstrate that the device is in conformity
with the standard identified in the declaration of conformity; or

‘(ii) that the standard identified in the declaration of
conformity is not applicable to the particular device under review.

‘(B) The Secretary may request, at any time, the data or
information relied on by the person to make a declaration of
conformity with respect to a standard recognized under paragraph (1).

‘(C) A person making a declaration of conformity with respect to a
standard recognized under paragraph (1) shall maintain the data and
information demonstrating conformity of the device to the standard
for a period of two years after the date of the classification or
approval of the device by the Secretary or a period equal to the
expected design life of the 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 declaration of
conformity submitted under section 514(c) or the failure or refusal
to provide data or information requested by the Secretary under
paragraph (3) of such section.’

(1) by striking ‘(e)’ and inserting ‘(e)(1)’; and

(2) by inserting at the end the following: ‘(2) If it is declared
to be, purports to be, or is represented as, a device that is in
conformity with any standard recognized under section 514(c) unless
such device is in all respects in conformity with such standard.’

(d) CONFORMING AMENDMENTS- Section 514(a) (21 U.S.C. 360d(a)) is
amended–

(1) in paragraph (1), in the second sentence, by striking ‘under
this section’ and inserting ‘under subsection (b)’;

(2) in paragraph (2), in the matter preceding subparagraph (A), by
striking ‘under this section’ and inserting ‘under subsection (b)’;

(3) in paragraph (3), by striking ‘under this section’ and
inserting ‘under subsection (b)’; and

(4) in paragraph (4), in the matter preceding subparagraph (A), by
striking ‘this section’ and inserting ‘this subsection and subsection
(b)’

(a) SECTION 513(a)- Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is
amended by adding at the end the following: ‘(C) In making a
determination of a reasonable assurance of the effectiveness of a
device for which an application under section 515 has been submitted,
the Secretary shall consider whether the extent of data that
otherwise would be required for approval of the application with
respect to effectiveness can be reduced through reliance on
postmarket controls.

‘(D)(i) The Secretary, upon the written request of any person
intending to submit an application under section 515, shall meet with
such person to determine the type of valid scientific evidence
(within the meaning of subparagraphs (A) and (B)) that will be
necessary to demonstrate for purposes of approval of an application
the effectiveness of a device for the conditions of use proposed by
such person. The written request shall include a detailed description
of the device, a detailed description of the proposed conditions of
use of the device, a proposed plan for determining whether there is a
reasonable assurance of effectiveness, and, if available, information
regarding the expected performance from the device. 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
such person.

‘(ii) Any clinical data, including one or more well-controlled
investigations, specified in writing by the Secretary for
demonstrating a reasonable assurance of device effectiveness shall be
specified as result of a determination by the Secretary that such
data are necessary to establish device effectiveness. The Secretary
shall consider, in consultation with the applicant, the least
burdensome appropriate means of evaluating device effectiveness that
would have a reasonable likelihood of resulting in approval.

‘(iii) The determination of the Secretary with respect to the
specification of valid scientific evidence under clauses (i) and (ii)
shall be binding upon the Secretary, unless such determination by the
Secretary could be contrary to the public health.’

(b) SECTION 513(i)- Section 513(i)(1) (21 U.S.C.
360c(i)(1)) is amended 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) of this section.

‘(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 request, the Secretary shall consider
the least burdensome means of demonstrating substantial equivalence
and request information accordingly.

‘(E)(i) Any determination by the Secretary of the intended use of
a device shall be based upon the proposed labeling submitted in a
report for the device under section 510(k). However, when determining
that a device can be found substantially equivalent to a legally
marketed device, the director of the organizational unit responsible
for regulating devices (in this subparagraph referred to as the
‘Director’) may require a statement in labeling that provides
appropriate information regarding a use of the device not identified
in the proposed labeling if, after providing an opportunity for
consultation with the person who submitted such report, the Director
determines and states in writing–

‘(I) that there is a reasonable likelihood that the device will be
used for an intended use not identified in the proposed labeling for
the device; and

‘(II) that such use could cause harm.

‘(ii) Such determination shall–

‘(I) be provided to the person who submitted the report within 10
days from the date of the notification of the Director’s concerns
regarding the proposed labeling;

‘(II) specify the limitations on the use of the device not
included in the proposed labeling; and

‘(III) find the device substantially equivalent if the
requirements of subparagraph (A) are met and if the labeling for such
device conforms to the limitations specified in subclause (II).

‘(iii) The responsibilities of the Director under this
subparagraph may not be delegated.

‘(iv) This subparagraph has no legal effect after the expiration
of the five-year period beginning on the date of the enactment of the
Food and Drug Administration Modernization Act of 1997.’

(1) in paragraph (1)(A), by adding after and below clause (ii) the
following: ‘In making the determination whether to approve or deny
the application, the Secretary shall rely on the conditions of use
included in the proposed labeling as the basis for determining
whether or not there is a reasonable assurance of safety and
effectiveness, if the proposed labeling is neither false nor
misleading. In determining whether or not such labeling is false or
misleading, the Secretary shall fairly evaluate all material facts
pertinent to the proposed labeling.’; and

(2) by adding after paragraph (5) (as added by section 202(2)) the
following: ‘(6)(A)(i) A supplemental application shall be required
for any change to a device subject to an approved application under
this subsection that affects safety or effectiveness, unless such
change is a modification in a manufacturing procedure or method of
manufacturing and the holder of the approved application submits a
written notice to the Secretary that describes in detail the change,
summarizes the data or information supporting the change, and informs
the Secretary that the change has been made under the requirements of
section 520(f).

‘(ii) The holder of an approved application who submits a notice
under clause (i) with respect to a manufacturing change of a device
may distribute the device 30 days after the date on which the
Secretary receives the notice, unless the Secretary within such
30-day period notifies the holder that the notice is not adequate and
describes such further information or action that is required for
acceptance of such change. If the Secretary notifies the holder that
a supplemental application is required, the Secretary shall review
the supplement within 135 days after the receipt of the supplement.
The time used by the Secretary to review the notice of the
manufacturing change shall be deducted from the 135-day review period
if the notice meets appropriate content requirements for premarket
approval supplements.

‘(B)(i) Subject to clause (ii), 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 such supplement if–

‘(I) nonclinical data demonstrate that the design modification
creates the intended additional capacity, function, or performance of
the device; and

‘(II) clinical data from the approved application and any
supplement to the approved application provide a reasonable assurance
of safety and effectiveness for the changed device.

‘(ii) The Secretary may require, when necessary, additional
clinical data to evaluate the design modification of the device to
provide a reasonable assurance of safety and effectiveness.’

SEC. 206. PREMARKET NOTIFICATION

(a) SECTION 510- Section 510 (21 U.S.C. 360) is amended–

(1) in subsection (k), in the matter preceding paragraph (1), by
adding after ‘report to the Secretary’ the following: ‘or person who
is accredited under section 523(a)’; and

(2) by adding at the end the following subsections: ‘(l) A report
under subsection (k) is not required for a device intended for human
use that is exempted from the requirements of this subsection under
subsection (m) or is within a type that has been classified into
class I under section 513. The exception established in the preceding
sentence does not apply to any class I device that is intended for a
use which is of substantial importance in preventing impairment of
human health, or to any class I device that presents a potential
unreasonable risk of illness or injury.

‘(m)(1) Not later than 60 days after the date of enactment of the
Food and Drug Administration Modernization Act of 1997, the Secretary
shall 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 as not
requiring the report shall be exempt from the requirement to provide
a report under subsection (k) as of the date of the publication of
the list in the Federal Register.

‘(2) Beginning on the date that is 1 day after the date of the
publication of a list under this subsection, the Secretary may exempt
a class II device from the requirement to submit a report under
subsection (k), upon the Secretary’s own initiative or a petition of
an interested person, if the Secretary determines that such report is
not necessary to assure the safety and effectiveness of the device.
The Secretary shall publish in the Federal Register notice of the
intent of the Secretary to exempt the device, or of the petition, and
provide a 30-day period for public comment. Within 120 days after the
issuance of the notice in the Federal Register, the Secretary shall
publish an order in the Federal Register that sets forth the final
determination of the Secretary regarding the exemption of the device
that was the subject of the notice. If the Secretary fails to respond
to a petition within 180 days of receiving it, the petition shall be
deemed to be granted.’

(b) SECTION 513(f)- Section 513(f) (21 U.S.C. 360c(f)) is amended
by adding at the end the following: ‘(5) The Secretary may not
withhold a determination of the initial classification of a device
under paragraph (1) because of a failure to comply with any provision
of this Act unrelated to a substantial equivalence decision,
including a finding that the facility in which the device is
manufactured is not in compliance with good manufacturing
requirements as set forth in regulations of the Secretary under
section 520(f) (other than a finding that there is a substantial
likelihood that the failure to comply with such regulations will
potentially present a serious risk to human health).’

(1) in subparagraph (A)(ii)– (A) in subclause (I), by striking
‘clinical data’ and inserting ‘appropriate clinical or scientific
data’ and by inserting ‘or a person accredited under section 523’
after ‘Secretary’; and (B) in subclause (II), by striking ‘efficacy’
and inserting ‘effectiveness’; and

(2) by adding at the end the following: ‘(F) Not later than 270
days after the date of the enactment of the Food and Drug
Administration Modernization Act of 1997, the Secretary shall issue
guidance specifying the general principles that the Secretary will
consider in determining when a specific intended use of a device is
not reasonably included within a general use of such device for
purposes of a determination of substantial equivalence under
subsection (f) or section 520(l).’

SEC. 207. EVALUATION OF AUTOMATIC CLASS III DESIGNATION

Section 513(f) (21 U.S.C. 360c(f)), as amended by section 206(b),
is amended–

(1) in paragraph (1)– (A) in subparagraph (B), by striking
‘paragraph (2)’ and inserting ‘paragraph (3)’; and (B) in the last
sentence, by striking ‘paragraph (2)’ and inserting ‘paragraph (2) or
(3)’;

(2) by redesignating paragraphs (2) and (3) as paragraphs (3) and
(4), respectively; and

(3) by inserting after paragraph (1) the following: ‘(2)(A) Any
person who submits a report under section 510(k) for a type of device
that has not been previously classified under this Act, and that is
classified into class III under paragraph (1), may request, within 30
days after receiving written notice of such a classification, the
Secretary to classify the device under the criteria set forth in
subparagraphs (A) through (C) of subsection (a)(1). The person may,
in the request, recommend to the Secretary a classification for the
device. Any such request shall describe the device and provide
detailed information and reasons for the recommended classification.

‘(B)(i) Not later than 60 days after the date of the submission of
the request under subparagraph (A), the Secretary shall by written
order classify the device involved. Such classification shall be the
initial classification of the device for purposes of paragraph (1)
and any device classified under this paragraph shall be a predicate
device for determining substantial equivalence under paragraph (1).

‘(ii) A device that remains in class III under this subparagraph
shall be deemed to be adulterated within the meaning of section
501(f)(1)(B) until approved under section 515 or exempted from such
approval under section 520(g).

‘(C) Within 30 days after the issuance of an order classifying a
device under this paragraph, the Secretary shall publish a notice in
the Federal Register announcing such classification.’

SEC. 208. CLASSIFICATION PANELS

Section 513(b) (21 U.S.C. 360c(b)) is amended by adding at the end
the following: ‘(5) Classification panels covering each type of
device shall be scheduled to meet at such times as may be appropriate
for the Secretary to meet applicable statutory deadlines.

‘(6)(A) Any person whose device is specifically the subject of
review by a classification panel shall have–

‘(i) the same access to data and information submitted to a
classification panel (except for data and information that are not
available for public disclosure under section 552 of title 5, United
States Code) as the Secretary;

‘(ii) the opportunity to submit, for review by a classification
panel, information that is based on the data or information provided
in the application submitted under section 515 by the person, which
information shall be submitted to the Secretary for prompt
transmittal to the classification panel; and

‘(iii) the same opportunity as the Secretary to participate in
meetings of the panel.

‘(B) Any meetings of a classification panel shall provide adequate
time for initial presentations and for response to any differing
views by persons whose devices are specifically the subject of a
classification panel review, and shall encourage free and open
participation by all interested persons.

‘(7) After receiving from a classification panel the conclusions
and recommendations of the panel on a matter that the panel has
reviewed, the Secretary shall review the conclusions and
recommendations, shall make a final decision on the matter in
accordance with section 515(d)(2), and shall notify the affected
persons of the decision in writing and, if the decision differs from
the conclusions and recommendations of the panel, shall include the
reasons for the difference.

‘(8) A classification panel under this subsection shall not be
subject to the annual chartering and annual report requirements of
the Federal Advisory Committee Act.’

(a) CERTAINTY OF REVIEW TIMEFRAMES- Section 510
(21 U.S.C. 360), as amended by section 206(a)(2), is amended by
adding at the end the following subsection: ‘(n) The Secretary shall
review the report required in subsection (k) and make a determination
under section 513(f)(1) not later than 90 days after receiving the
report.’

(b) COLLABORATIVE REVIEW PROCESS- Section 515(d) (21 U.S.C
360e(d)), as amended by section 202(1), is amended by inserting after
paragraph (2) the following: ‘(3)(A)(i) The Secretary shall, upon the
written request of an applicant, meet with the applicant, not later
than 100 days after the receipt of an application that has been filed
as complete under subsection (c), to discuss the review status of the
application.

‘(ii) The Secretary shall, in writing and prior to the meeting,
provide to the applicant a description of any deficiencies in the
application that, at that point, have been identified by the
Secretary based on an interim review of the entire application and
identify the information that is required to correct those
deficiencies.

‘(iii) The Secretary shall notify the applicant promptly of–

‘(I) any additional deficiency identified in the application, or

‘(II) any additional information required to achieve completion of
the review and final action on the application, that was not
described as a deficiency in the written description provided by the
Secretary under clause (ii).

‘(B) The Secretary and the applicant may, by mutual consent,
establish a different schedule for a meeting required under this
paragraph.

(a) IN GENERAL- Subchapter A of chapter V is
amended by adding at the end the following:

‘SEC. 523. ACCREDITED PERSONS

‘(a) IN GENERAL-

‘(1) REVIEW AND CLASSIFICATION OF DEVICES- Not later than 1 year
after the date of the enactment of the Food and Drug Administration
Modernization Act of 1997, the Secretary shall, subject to paragraph
(3), accredit persons for the purpose of reviewing reports submitted
under section 510(k) and making recommendations to the Secretary
regarding the initial classification of devices under section
513(f)(1).

‘(2) REQUIREMENTS REGARDING REVIEW- ‘(A) IN GENERAL- In making a
recommendation to the Secretary under paragraph (1), an accredited
person shall notify the Secretary in writing of the reasons for the
recommendation.

‘(B) TIME PERIOD FOR REVIEW- Not later than 30 days after the date
on which the Secretary is notified under subparagraph (A) by an
accredited person with respect to a recommendation of an initial
classification of a device, the Secretary shall make a determination
with respect to the initial classification.

‘(C) SPECIAL RULE- The Secretary may change the initial
classification under section 513(f)(1) that is recommended under
paragraph (1) by an accredited person, and in such case shall provide
to such person, and the person who submitted the report under section
510(k) for the device, a statement explaining in detail the reasons
for the change.

‘(3) CERTAIN DEVICES- ‘(A) IN GENERAL- An accredited person may
not be used to perform a review of– ‘(i) a class III device; ‘(ii) a
class II device which is intended to be permanently implantable or
life sustaining or life supporting; or ‘(iii) a class II device which
requires clinical data in the report submitted under section 510(k)
for the device, except that the number of class II devices to which
the Secretary applies this clause for a year, less the number of such
reports to which clauses (i) and (ii) apply, may not exceed 6 percent
of the number that is equal to the total number of reports submitted
to the Secretary under such section for such year less the number of
such reports to which such clauses apply for such year.

‘(B) ADJUSTMENT- In determining for a year the ratio described in
subparagraph (A)(iii), the Secretary shall not include in the
numerator class III devices that the Secretary reclassified into
class II, and the Secretary shall include in the denominator class II
devices for which reports under section 510(k) were not required to
be submitted by reason of the operation of section 510(m).

‘(b) ACCREDITATION-

‘(1) PROGRAMS- The Secretary shall provide for such accreditation
through programs administered by the Food and Drug Administration,
other government agencies, or by other qualified nongovernment
organizations.

‘(2) ACCREDITATION- ‘(A) IN GENERAL- Not later than 180 days after
the date of the enactment of the Food and Drug Administration
Modernization Act of 1997, the Secretary shall establish and publish
in the Federal Register criteria to accredit or deny accreditation to
persons who request to perform the duties specified in subsection
(a). The Secretary shall respond to a request for accreditation
within 60 days of the receipt of the request. The accreditation of
such person shall specify the particular activities under subsection
(a) for which such person is accredited.

‘(B) WITHDRAWAL OF ACCREDITATION- The Secretary may suspend or
withdraw accreditation of any person accredited under this paragraph,
after providing notice and an opportunity for an informal hearing,
when such person is substantially not in compliance with the
requirements of this section or poses a threat to public health or
fails to act in a manner that is consistent with the purposes of this
section.

‘(C) PERFORMANCE AUDITING- To ensure that persons accredited under
this section will continue to meet the standards of accreditation,
the Secretary shall– ‘(i) make onsite visits on a periodic basis to
each accredited person to audit the performance of such person; and
‘(ii) take such additional measures as the Secretary determines to be
appropriate.

‘(D) ANNUAL REPORT- The Secretary shall include in the annual
report required under section 903(g) the names of all accredited
persons and the particular activities under subsection (a) for which
each such person is accredited and the name of each accredited person
whose accreditation has been withdrawn during the year.

‘(3) QUALIFICATIONS- An accredited person shall, at a minimum,
meet the following requirements: ‘(A) Such person may not be an
employee of the Federal Government.

‘(B) Such person shall be an independent organization which is not
owned or controlled by a manufacturer, supplier, or vendor of devices
and which has no organizational, material, or financial affiliation
with such a manufacturer, supplier, or vendor.

‘(C) Such person shall be a legally constituted entity permitted
to conduct the activities for which it seeks accreditation.

‘(D) Such person shall not engage in the design, manufacture,
promotion, or sale of devices.

‘(E) The operations of such person shall be in accordance with
generally accepted professional and ethical business practices and
shall agree in writing that as a minimum it will– ‘(i) certify that
reported information accurately reflects data reviewed; ‘(ii) limit
work to that for which competence and capacity are available; ‘(iii)
treat information received, records, reports, and recommendations as
proprietary information; ‘(iv) promptly respond and attempt to
resolve complaints regarding its activities for which it is
accredited; and ‘(v) protect against the use, in carrying out
subsection (a) with respect to a device, of any officer or employee
of the person who has a financial conflict of interest regarding the
device, and annually make available to the public disclosures of the
extent to which the person, and the officers and employees of the
person, have maintained compliance with requirements under this
clause relating to financial conflicts of interest.

‘(4) SELECTION OF ACCREDITED PERSONS- The Secretary shall provide
each person who chooses to use an accredited person to receive a
section 510(k) report a panel of at least two or more accredited
persons from which the regulated person may select one for a specific
regulatory function.

‘(5) COMPENSATION OF ACCREDITED PERSONS- Compensation for an
accredited person shall be determined by agreement between the
accredited person and the person who engages the services of the
accredited person, and shall be paid by the person who engages such
services.

‘(c) DURATION- The authority provided by this section terminates–

‘(1) 5 years after the date on which the Secretary notifies
Congress that at least 2 persons accredited under subsection (b) are
available to review at least 60 percent of the submissions under
section 510(k), or

‘(2) 4 years after the date on which the Secretary notifies
Congress that the Secretary has made a determination described in
paragraph (2)(B) of subsection (a) for at least 35 percent of the
devices that are subject to review under paragraph (1) of such
subsection, whichever occurs first.’

(b) RECORDKEEPING- Section 704 (21 U.S.C. 374) is amended by
adding at the end the following: ‘(f)(1) A person accredited under
section 523 to review reports made under section 510(k) and make
recommendations of initial classifications of devices to the
Secretary shall maintain records documenting the training
qualifications of the person and the employees of the person, the
procedures used by the person for handling confidential information,
the compensation arrangements made by the person, and the procedures
used by the person to identify and avoid conflicts of interest. Upon
the request of an officer or employee designated by the Secretary,
the person shall permit the officer or employee, at all reasonable
times, to have access to, to copy, and to verify, the records.

‘(2) Within 15 days after the receipt of a written request from
the Secretary to a person accredited under section 523 for copies of
records described in paragraph (1), the person shall produce the
copies of the records at the place designated by the Secretary.’

(c) CONFORMING AMENDMENT- Section 301 (21 U.S.C. 331), as amended
by section 204(b), is amended by adding at the end the following:
‘(y) In the case of a drug, device, or food–

‘(1) the submission of a report or recommendation by a person
accredited under section 523 that is false or misleading in any
material respect;

‘(2) the disclosure by a person accredited under section 523 of
confidential commercial information or any trade secret without the
express written consent of the person who submitted such information
or secret to such person; or

‘(3) the receipt by a person accredited under section 523 of a
bribe in any form or the doing of any corrupt act by such person
associated with a responsibility delegated to such person under this
Act.’

(d) REPORTS ON PROGRAM OF ACCREDITATION-

(1) COMPTROLLER GENERAL- (A) IMPLEMENTATION OF PROGRAM- Not later
than 5 years after the date of the enactment of this Act, the
Comptroller General of the United States shall submit to the
Committee on Commerce of the House of Representatives and the
Committee on Labor and Human Resources of the Senate a report
describing the extent to which the program of accreditation required
by the amendment made by subsection (a) has been implemented.

(B) EVALUATION OF PROGRAM- Not later than 6 months prior to the
date on which, pursuant to subsection (c) of section 523 of the
Federal Food, Drug, and Cosmetic Act (as added by subsection (a)),
the authority provided under subsection (a) of such section will
terminate, the Comptroller General shall submit to the Committee on
Commerce of the House of Representatives and the Committee on Labor
and Human Resources of the Senate a report describing the use of
accredited persons under such section 523, including an evaluation of
the extent to which such use assisted the Secretary in carrying out
the duties of the Secretary under such Act with respect to devices,
and the extent to which such use promoted actions which are contrary
to the purposes of such Act.

(2) INCLUSION OF CERTAIN DEVICES WITHIN PROGRAM- Not later than 3
years after the date of the enactment of this Act, the Secretary of
Health and Human Services shall submit to the Committee on Commerce
of the House of Representatives and the Committee on Labor and Human
Resources of the Senate a report providing a determination by the
Secretary of whether, in the program of accreditation established
pursuant to the amendment made by subsection (a), the limitation
established in clause (iii) of section 523(a)(3)(A) of the Federal
Food, Drug, and Cosmetic Act (relating to class II devices for which
clinical data are required in reports under section 510(k)) should be
removed.

SEC. 211. DEVICE TRACKING

Effective 90 days after the date of the enactment of this Act,
section 519(e) (21 U.S.C. 360i(e)) is amended to read as follows:

‘DEVICE TRACKING ‘(e)(1) The Secretary may by order require a
manufacturer to adopt a method of tracking a class II or class III
device–

‘(A) the failure of which would be reasonably likely to have
serious adverse health consequences; or

‘(B) which is– ‘(i) intended to be implanted in the human body
for more than one year, or ‘(ii) a life sustaining or life supporting
device used outside a device user facility

‘(2) Any patient receiving a device subject to tracking under
paragraph (1) may refuse to release, or refuse permission to release,
the patient’s name, address, social security number, or other
identifying information for the purpose of tracking.’

SEC. 212. POSTMARKET SURVEILLANCE

Effective 90 days after the date of the enactment of this Act,
section 522 (21 U.S.C. 360l) is amended to read as follows:

‘POSTMARKET SURVEILLANCE ‘SEC. 522. (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 562.’

SEC. 213. REPORTS

(a) REPORTS- Section 519 (21 U.S.C. 360i) is amended–

(1) in subsection (a)– (A) in the matter preceding paragraph (1),
by striking ‘manufacturer, importer, or distributor’ and inserting
‘manufacturer or importer’; (B) in paragraph (4), by striking
‘manufacturer, importer, or distributor’ and inserting ‘manufacturer
or importer’; (C) in paragraph (7), by adding ‘and’ after the
semicolon at the end; (D) in paragraph (8)– (i) by striking
‘manufacturer, importer, or distributor’ each place such term appears
and inserting ‘manufacturer or importer’; and (ii) by striking the
semicolon at the end and inserting a period; (E) by striking
paragraph (9); and (F) by inserting at the end the following
sentence: ‘The Secretary shall by regulation require distributors to
keep records and make such records available to the Secretary upon
request. Paragraphs (4) and (8) apply to distributors to the same
extent and in the same manner as such paragraphs apply to
manufacturers and importers.’;

(2) by striking subsection (d); and

(3) in subsection (f), by striking ‘, importer, or distributor’
each place it appears and inserting ‘or importer’.

(b) REGISTRATION- Section 510(g) (21 U.S.C. 360(g)) is amended–

(1) by redesignating paragraph (4) as paragraph (5);

(2) by inserting after paragraph (3) the following:

‘(4) any distributor who acts as a wholesale distributor of
devices, and who does not manufacture, repackage, process, or relabel
a device; or’; and

(3) by adding at the end the following flush sentence: ‘In this
subsection, the term ‘wholesale distributor’ means any person (other
than the manufacturer or the initial importer) who distributes a
device from the original place of manufacture to the person who makes
the final delivery or sale of the device to the ultimate consumer or
user.’

(1) IN GENERAL- Section 519(b) (21 U.S.C. 360i(b)) is amended–
(A) in paragraph (1)(C)– (i) in the first sentence, by striking ‘a
semi-annual basis’ and inserting ‘an annual basis’; (ii) in the
second sentence, by striking ‘and July 1’; and (iii) by striking the
matter after and below clause (iv); and (B) in paragraph (2)– (i) in
subparagraph (A), by inserting ‘or’ after the comma at the end; (ii)
in subparagraph (B), by striking ‘, or’ at the end and inserting a
period; and (iii) by striking subparagraph (C)

(2) SENTINEL SYSTEM- Section 519(b) (21 U.S.C. 360i(b)) is
amended– (A) by redesignating paragraph (5) as paragraph (6); and
(B) by inserting after paragraph (4) the following paragraph: ‘(5)
With respect to device user facilities:

‘(A) The Secretary shall by regulation plan and implement a
program under which the Secretary limits user reporting under
paragraphs (1) through (4) to a subset of user facilities that
constitutes a representative profile of user reports for device
deaths and serious illnesses or serious injuries.

‘(B) During the period of planning the program under subparagraph
(A), paragraphs (1) through (4) continue to apply.

‘(C) During the period in which the Secretary is providing for a
transition to the full implementation of the program, paragraphs (1)
through (4) apply except to the extent that the Secretary determines
otherwise.

‘(D) On and after the date on which the program is fully
implemented, paragraphs (1) through (4) do not apply to a user
facility unless the facility is included in the subset referred to in
subparagraph (A).

‘(E) Not later than 2 years after the date of the enactment of the
Food and Drug Administration Modernization Act of 1997, the Secretary
shall submit to the Committee on Commerce of the House of
Representatives, and to the Committee on Labor and Human Resources of
the Senate, a report describing the plan developed by the Secretary
under subparagraph (A) and the progress that has been made toward the
implementation of the plan.’

SEC. 214. PRACTICE OF MEDICINE

Chapter IX is amended by adding at the end the following:

‘SEC. 906. PRACTICE OF MEDICINE

‘Nothing in this Act shall be construed to limit or interfere with
the authority of a health care practitioner to prescribe or
administer any legally marketed device to a patient for any condition
or disease within a legitimate health care practitioner-patient
relationship. This section shall not limit any existing authority of
the Secretary to establish and enforce restrictions on the sale or
distribution, or in the labeling, of a device that are part of a
determination of substantial equivalence, established as a condition
of approval, or promulgated through regulations. Further, this
section shall not change any existing prohibition on the promotion of
unapproved uses of legally marketed devices.’

SEC. 215. NONINVASIVE BLOOD GLUCOSE METER

(a) FINDINGS- The Congress finds that–

(1) diabetes and its complications are a leading cause of death by
disease in America;

(2) diabetes affects approximately 16,000,000 Americans and
another 650,000 will be diagnosed in 1997;

(3) the total health care-related costs of diabetes total nearly
$100,000,000,000 per year;

(4) diabetes is a disease that is managed and controlled on a
daily basis by the patient;

(5) the failure to properly control and manage diabetes results in
costly and often fatal complications including but not limited to
blindness, coronary artery disease, and kidney failure;

(6) blood testing devices are a critical tool for the control and
management of diabetes, and existing blood testing devices require
repeated piercing of the skin;

(7) the pain associated with existing blood testing devices
creates a disincentive for people with diabetes to test blood glucose
levels, particularly children;

(8) a safe and effective noninvasive blood glucose meter would
likely improve control and management of diabetes by increasing the
number of tests conducted by people with diabetes, particularly
children; and

(9) the Food and Drug Administration is responsible for reviewing
all applications for new medical devices in the United States.

(b) SENSE OF CONGRESS- It is the sense of the Congress that the
availability of a safe, effective, noninvasive blood glucose meter
would greatly enhance the health and well-being of all people with
diabetes across America and the world.

(a) USE OF DATA RELATING TO PREMARKET APPROVAL-

(1) IN GENERAL- Section 520(h)(4) (21 U.S.C. 360j(h)(4)) is
amended to read as follows: ‘(4)(A) Any information contained in an
application for premarket approval filed with the Secretary pursuant
to section 515(c) (including information from clinical and
preclinical tests or studies that demonstrate the safety and
effectiveness of a device, but excluding descriptions of methods of
manufacture and product composition and other trade secrets) shall be
available, 6 years after the application has been approved by the
Secretary, for use by the Secretary in–

‘(i) approving another device;

‘(ii) determining whether a product development protocol has been
completed, under section 515 for another device;

‘(iii) establishing a performance standard or special control
under this Act; or

‘(iv) classifying or reclassifying another device under section
513 and subsection (l)(2)

‘(B) The publicly available detailed summaries of information
respecting the safety and effectiveness of devices required by
paragraph (1)(A) shall be available for use by the Secretary as the
evidentiary basis for the agency actions described in subparagraph
(A).’

(2) CONFORMING AMENDMENTS- Section 517(a) (21 U.S.C. 360g(a)) is
amended– (A) in paragraph (8), by adding ‘or’ at the end; (B) in
paragraph (9), by striking ‘, or’ and inserting a comma; and (C) by
striking paragraph (10).

(b) PRODUCT DEVELOPMENT PROTOCOL- Section
515(f)(2) (21 U.S.C 360e(f)(2)) is amended by striking ‘he shall’ and
all that follows and inserting the following: ‘the Secretary–

‘(A) may, at the initiative of the Secretary, refer the proposed
protocol to the appropriate panel under section 513 for its
recommendation respecting approval of the protocol; or

‘(B) shall so refer such protocol upon the request of the
submitter, unless the Secretary finds that the proposed protocol and
accompanying data which would be reviewed by such panel substantially
duplicate a product development protocol and accompanying data which
have previously been reviewed by such a panel.’

Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended by
striking ‘clinical investigations’ and inserting ‘1 or more clinical
investigations’.