‘‘(5) Classification panels covering each type of device
shall be scheduled to meet at least 6 times each calendar
year to consider, among other things, the approval of ap-
plications submitted to the Secretary under section 515.
Such meetings shall, to the extent possible, be scheduled
at equal intervals throughout the year. Such meetings
shall be held with the physical presence of panel members
at least 3 times each calendar year. Other meetings of the
panel may be held using electronic communication to con-
vene the meeting.
‘‘(6) Each member of a panel shall publically disclose
all conflicts of interest that member may have with the
work to be undertaken by the panel. No member of a panel
may vote on any matter where the member could gain fi-
nancially from the advice given to the Secretary. The Sec-
retary may grant a waiver of any conflict of interest upon
public disclosure of such conflict of interest if such waiver
contributes to the ability of a panel to contribute to the
public health, except that the Secretary may not grant a
waiver for a member of a panel when the member’s own
scientific work is involved.
‘‘(7) The Secretary shall provide education and train-
ing to each new panel member before such member partici-
pates in a panel’s activities. Such education and training
shall include a familiarization with certain requirements
under this Act and any related regulation of the Secretary
and the administrative process and procedures related to
panel meetings.
‘‘(8) The Secretary shall take whatever action is nec-
essary to ensure that regular meetings are held by sci-
entific advisory panels, at appropriate intervals and for a
sufficient length of time, so that any matter to be reviewed
by any such panel shall be presented to the panel not more
than 60 days after the matter is ready for review by the
panel. The meetings shall occur not less than 6 times each
year unless there are compelling reasons for fewer meet-
ings. Such meetings shall be held with the physical pres-
ence of panel members at least 3 times each calendar year.
Other meetings of the panel may be held using electronic
communication to convene the meeting.
‘‘(9)(A) All persons, including employees of the Sec-
retary, shall have the same rights and responsibilities re-
garding—
‘‘(i) the submission of data and information to,
and contact and discussion with, a classification
panel;
‘‘(ii) the participation of the persons at meet-
ings of the panel; and
‘‘(iii) access to data and information submitted
to a classification panel (except for data and infor-
mation that are not available for public disclosure
under section 552 of title 5, United States Code).
‘‘(B) In a case in which a classification panel reviews
a submission under section 510(k), all related data and
information that are not available for public disclosure
under section 552 of title 5, United States Code, shall be
exchanged between the person who submitted such notice
and the Food and Drug Administration at the time the
data and information are submitted to such panel but
shall not otherwise be publicly disclosed.
‘‘(C) Any meetings of a classification panel shall pro-
vide adequate time for initial presentations and for re-
sponse to any differing views and shall encourage free and
open participation by all interested persons.
‘‘(10) Within 30 days after the date a classification
panel makes its conclusions and recommendations on any
matter under review by the panel, the Food and Drug Ad-
ministration official responsible for the matter shall review
the conclusions and recommendations of the panel, shall
make a final decision on the matter, and shall notify the
affected persons of the decision in writing and, if the deci-
sion differs from the conclusions and recommendations of
the panel, shall include the reasons for the difference.
‘‘(11) A scientific advisory panel under this sub-
section shall not be subject to the annual chartering and
annual report requirements of the Federal Advisory Com-
mittee Act. Such a panel shall make an annual report of
its activities to the Secretary.’’.
SEC. 11. PREMARKET APPROVAL.
(a) SECTION 515(c).—Section 515(c) (21 U.S.C.
360e(c)) is amended—
(1) in the first sentence of paragraph (1), by
inserting immediately before the period the follow-
ing: ‘‘or may file such application with a person au-
thorized to review applications for premarket ap-
proval under section 712’’; and
(2) by adding after paragraph (2) the following:
‘‘(3)(A) The scope of review responsibilities of accred-
ited persons authorized to conduct reviews of premarket
approval applications under section 712 shall include—
‘‘(i) the receipt and filing of applications for
substantive review;
‘‘(ii) the review of applications to determine
whether there is a reasonable assurance that a de-
vice is safe and effective for its labeled uses;
‘‘(iii) the review of applications in accordance
with the schedule for review identified in subsection
(d)(2) unless such organization or person by con-
tract with an applicant alters such schedule or elimi-
nates any item of review but not the review by a
classification panel under paragraph (2);
‘‘(iv) the presentation, when appropriate, of
such applications to a classification panel constituted
under section 513(b); and
‘‘(v) the evaluation of classification panel rec-
ommendations and premarket approval applications
and the formulation of reports and recommendations
to be submitted to the Secretary no later than 30
days after receipt of a classification panel’s rec-
ommendation.
Recommendations to the Secretary shall specify whether
an application should be approved or denied and shall
state the basis for the recommendation.
‘‘(B) The recommendation of an accredited person to
approve or deny an application shall be considered to be
an order of the Secretary unless the Secretary finds that
there is a reasonable probability that the device is not safe
or effective. In the event that the Secretary makes such
a finding, the Secretary shall provide a detailed expla-
nation of the basis of the finding.’’.
(b) SECTION 515(d).—Section 515(d) (21 U.S.C.
360e(d)) is amended by redesignating paragraphs (2) and
(3) as paragraphs (5) and (6), respectively, by adding be-
fore the semicolon at the end of paragraph (5)(B) (as so
redesignated) the following: ‘‘and for purposes of this sub-
paragraph, the determination of a reasonable assurance
that a device is effective under the conditions of use pre-
scribed, recommended, or suggested in proposed labeling
shall not include uses or indications for use not identified
in the application’’, and by adding after paragraph (1) the
following:
‘‘(2) Each application received under subsection (c)
shall be reviewed in the following manner to achieve final
action on such applications within 180 days of its receipt:
‘‘(A) The Secretary shall determine, within 30
days of the receipt of an application submitted under
subsection (c), whether the application satisfies the
content requirements of subsection (c)(1) and appli-
cable regulations.
‘‘(B) The Secretary shall meet with an appli-
cant on request within 90 days of receipt of an ap-
plication that has been accepted for filing to discuss
the review status of the application. If the applica-
tion does not appear in a form that would neces-
sitate an approval under this subsection, the Sec-
retary shall, in writing and prior to the meeting,
present to the applicant a description of any defi-
ciencies with the application and what information
would be necessary to bring the application into a
form that would require an approval.
‘‘(C) The Secretary shall refer an application to
a classification panel established under section 513
for review and an approval recommendation, unless
a panel is not required under subsection (c)(2), with-
in 30 days of the meeting referred to in subpara-
graph (B). The application shall be reviewed at the
next scheduled panel meeting.
‘‘(D) The Secretary shall, within 15 days before
the date of a panel review, provide to an applicant
a statement of each view or position the Secretary
has communicated or intends to communicate to a
classification panel constituted under section 513(b)
or any panel member regarding a premarket ap-
proval application scheduled for a panel review. Ad-
ditionally, at this time the Secretary shall provide to
the applicant all information provided by the Sec-
retary to such panel regarding the review of a pre-
market application.
‘‘(E) The Secretary shall meet not later than
10 days after the panel review to present to an ap-
plicant a description of all additional information
necessary to require an approval of an application
under paragraph (1)(A) if the Secretary has deter-