Guidance
for Industry and FDA Staff
Guidance on Amended Procedures for Advisory Panel Meetings
Document issued on: July 22, 2000
This document supersedes the document entitled "Guidance
on Amended Procedures for Advisory Panel Meetings" dated 1/26/99.
|
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation
Office of the Director |
Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency
consideration to Nancy J. Pluhowski, Office of Device Evaluation, HFZ-400,
9200 Corporate Boulevard, Rockville, MD 20850, or William Freas, Center for
Biologics Evaluation and Research (HFM-21) 1401 Rockville Pike, Rockville,
MD 20852. Comments may not be acted upon by the Agency until the document is
next revised or updated. For questions regarding the use or interpretation
of this guidance contact Nancy J. Pluhowski (CDRH) at (301) 594-2022, or
William Freas (CBER) at (301) 827-1295.
Additional Copies
World Wide Web/CDRH home page at http://www.fda.gov/cdrh/modact/amendpan.pdf
or CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number
413 when prompted for the document shelf number.
Guidance on Amended Procedures for
Advisory Panel Meetings1
Purpose
The purpose of this guidance is to establish standard operating procedures to
be followed by the Center for Devices and Radiological Health (CDRH), the Center
for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA)
personnel and interested persons outside FDA, in carrying out Section 513 (b)(6)
of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by Section 208
of the FDA Modernization Act of 1997 (FDAMA). The standard operating procedures
outlined below apply to advisory panel meetings where a specific submission is
being considered by the panel.
Background on the New Provision
As stipulated in the new Section 513 (b)(6)(A)(i) of the Act, FDA is required
to provide, to any person whose device is specifically the subject of a
classification panel review, the same access to data and information about the
device as that submitted to a classification panel, except for data and
information that are not available for public disclosure under {5 U.S.C. 552}.
In accordance with Section 513 (b)(6)(A)(ii), FDA is required to provide to
such persons the opportunity to submit information, based on the data or
information provided in the application under review, to the panel for its
review.
Section 513 (b)(6)(A)(iii) amended the Act to also allow such persons the
same opportunity as FDA to participate in meetings of the panel.
Section 513 (b)(6)(B) of the Act requires of device classification panel
meetings that: (1) adequate time be provided for initial presentations; (2)
adequate time be provided for response to any differing views by persons whose
devices are the subject of a classification panel; and (3) free and open
participation by all interested persons be encouraged.
1This document
is intended to provide guidance. It represents the Agency’s current thinking
on the above. It does not create or
confer any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may
be used if such approach satisfies the requirements of the applicable statute,
regulations, or both.
Standard Operating Procedures
- Premeeting Mailouts
- At least 3 weeks before a device classification panel meeting to
consider an action on a specific sponsor’s device, FDA will provide to
the panel members and the sponsor a prepared panel package (all
pre-meeting materials that are sent to the entire panel, except for the
industry representative who may receive a package that has been redacted
at the sponsor’s request) which contains:
- appropriate sections of the product submission (i.e. preclinical and
clinical data, summary of safety and effectiveness, labeling),
- related information submitted by the sponsor,
- FDA review memos (preclinical, clinical, statistical), or a summary of
the FDA review memos,
- FDA questions for panel consideration, and
- outline or slides prepared for an FDA presentation (if available).
- The following timeline and preparation of the panel package is
recommended:
- When available, but generally by six weeks before an advisory
panel meeting, FDA will send to the sponsor an index of materials the
Agency intends to include in the panel package. FDA will ask the sponsor
to determine whether there is any additional information, directly
related to the submission that the sponsor wants to include in the panel
package.
- The sponsor will therefore have approximately two weeks to submit
additional information to be distributed to the panel. Such information
should include a complete table of contents and an index. To be included
in the initial panel package, the information should arrive at the
Agency at least four weeks before the advisory panel meeting. The
sponsor is asked to provide twenty copies of this information.
- Upon receipt of the sponsor's materials for the panel package, FDA
will assess the proposed panel package for completeness and relevance.
FDA will determine if the added information is based on data or
information in the PMA. Any question about the relatedness of the
additional information will be discussed by telephone with the sponsor.
This discussion will occur prior to the Agency’s redacting material
not based on data or information provided in the application.
- FDA will send the complete panel package to the panel members and the
sponsor simultaneously. Additional pertinent information, available to
FDA after the initial panel package has been distributed, will be
provided to the panel and sponsor as a panel package addendum. FDA will
make every effort to mail the addendum package, if there is one, one
week before the advisory panel meeting.
- In general, new data, analyses, or information from a sponsor, will
not be provided to the panel within 2 weeks of the panel meeting, or at
the meeting itself, unless it is responsive to questions [on the
existing, evaluated set of data] identified by FDA or the panel. The
additional information should not be of a type that could trigger a
major amendment to the PMA. Additional information of this type may lead
to the postponement of the advisory panel meeting to a later date.
- FDA will provide the sponsor an equal amount of time to address the
advisory panel as described below:
- In order to provide adequate time for panel deliberations and at the
discretion of the Chair:
- The sponsor will generally be provided 60 minutes (up to 90 minutes if
the sponsor requests and the Chair agrees they need additional time due
to special circumstances) to present a submission to the advisory panel.
- FDA's presentation will usually be limited to 60 minutes (similarly up
to 90 minutes due to special circumstances) and will include specific
issues identified during the review process, unresolved issues, and
deficiencies in the submission.
- Following initial presentations, the sponsor and FDA, respectively,
will each be provided equal opportunities (up to 15 minutes) to clarify
issues or information presented during the panel meeting.
- The panel may require clarification during the panel’s deliberations
and before a vote is taken on the submission. In such cases, both FDA
and the sponsor will be provided an equal opportunity to respond.
- Encourage free and open participation by all interested persons:
- The open public session of the advisory committee meeting provides a
time for free and open participation by all interested persons.
- Generally, the open public session lasts one hour and will be
conducted in two segments: approximately 30 minutes at the beginning of
the panel meeting for general or specific issues and 30 minutes near the
end of the panel deliberations, prior to the vote, for interested
persons to address issues specific to the submission before the panel.
These standard operating procedures also will be applied to device
classification panel meetings on issues involving more than one sponsor. In such
cases, however, the time available per sponsor may be more limited than
indicated above. Further discussion of these procedures will be in the revised
Policy and Guidance Handbook for FDA's Advisory Committees.
Updated 7/25/2000
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