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IDE Refuse to Accept Procedures
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This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer 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. This guidance will be updated in the next revision to include the standard elements of GGP’s.
Deputy Director, Office of Device Evaluation (HFZ-400)
IDE Refuse to Accept Procedures
ODE Review Staff
Purpose
The purpose of this memorandum is to establish procedures under which
an IDE that does not meet a minimum threshold of acceptability will not
be accepted for substantive review and approval.
Background
The Office of Device Evaluation (ODE) receives approximately 225
original Investigational Device Exemptions (IDE) submissions each year.
Many of these applications are incomplete or grossly inadequate, i.e.,
they fail to contain information clearly required under the regulations
and they fail to contain the components necessary to allow substantive
review. An IDE application that is missing any of the elements of 21
CFR 812.20, is technically an incomplete application and, therefore,
not subject to the 30 day review clock. As a means to employ ODE
resources more effectively, these procedures are being implemented to
ensure that IDEs meet a minimum threshold of acceptability; otherwise,
ODE will refuse to accept the application. These procedures will
benefit both FDA and IDE sponsors.
A primary goal in establishing these "Refuse to Accept Procedures" for
IDEs is to improve the use of our review resources by ensuring that
they are focused on the review of reasonably complete and well-
supported applications. Often, during initial substantive review, ODE
has found that crucial information necessary to make a decision to
approve or disapprove an IDE has been omitted. When making a decision
to accept or not to accept an application, ODE will identify those
applications in which sufficient information is submitted to allow a
decision on the approvability of the investigation (i.e., the
application is complete on its face). By establishing these procedures
with criteria for completeness of an application that are clear,
consistent, and available to sponsors, they will know what is
expected of them for each submission and device they intend to
investigate. Sponsors will be likely to comply with the established
criteria to speed the time to substantive review of and a final
decision on their application.
These procedures are based upon the Management Action Plan (MAP)
initiative issue paper entitled "Center for Devices and Radiological
Health's Investigational Device Exemptions (IDE) Refuse to Accept
Policy." This Blue Book Memorandum embodies the guidance procedures
flowing from that issue paper and hereby replaces that document as the
policy of ODE. Attached to the MAP issue paper was a document entitled
"IDE Refuse to Accept Criteria" and an accompanying checklist. As
described below, these criteria and the checklist will be used by ODE
reviewers in applying these guidance procedures to the review of
incoming IDEs.
In general, there are three bases for refusal to accept an IDE:
1. An approved IDE is not required for the investigation.
2. The application omits a section of the IDE required under
the IDE regulation, 21 CFR Part 812.
3. The application fails to address generally accepted scientific
and professional principles governing the conduct of clinical
trials or scientific/technical issues clearly described in
general, device-specific, and crosscutting guidance documents
made publicly available by FDA.
The checklist that accompanies the "IDE Refuse to Accept Criteria" is a
general checklist. Divisions may modify or supplement this general
checklist based on available guidance documents appropriate to their
specific device areas. Division guidance documents should be
promulgated wherever needs are identified. Guidances should provide
specific details about what is expected and acceptable for all
components of the submissions. Each product specific guidance should
include a checklist to be used by a) the applicant in preparing the
submission and b) reviewers during the initial evaluation to consider
accepting the application for full review. Checklists should also be
prepared for existing guidelines. This will save time and provide
consistency across submissions. Also, emphasis should be placed on
improved communication with industry.
In addition to the copies that are being made available to ODE
reviewers, the document, "IDE Refuse to Accept Criteria" and any device
specific guidance documents and checklists developed by the divisions
are being made available to manufacturers and other members of the
public by the Center's Division of Small Manufacturers Assistance.
Procedures
This guidance memorandum will be implemented by the review divisions
within the Office of Device Evaluation utilizing the following
procedures. The specific timeframes are goals that will be met to the
extent permitted by available resources.
1. Processing
a. The ODE Document Mail Center (DMC) will log in and jacket the
IDE and forward it to the IDE Staff. The IDE Staff will
conduct a preliminary review to verify that the submission is
an IDE, and that it is administratively complete. If grossly
administratively incomplete, the IDE Staff will issue an
incomplete letter. If the submission is administratively
complete, it will be forwarded to the appropriate review
division within 2 days of receipt of the application in the
DMC or as quickly as available resources allow.
b. A designated reviewer (Branch Chief, Reviewer, CSO, CST),
using the IDE Refuse to Accept Criteria and checklist, and
other appropriate device specific checklists, will determine
whether the IDE is sufficiently complete to allow substantive
review. The division should consult with the Program
Operations Staff (POS) on any decision that is particularly
difficult or controversial.
c. Refuse to Accept recommendation(s) will be forwarded to the
appropriate supervisor for concurrence within 10 days of DMC's
receipt.
d. If an application is found to be sufficiently complete to
allow substantive review, the IDE will be placed into the
queue for substantive review.
e. If an application is found to be insufficiently complete to
allow substantive review, a Refuse to Accept letter will be
prepared, in coordination with the POS Staff, for the Division
Director's signature. The Refuse to Accept letter, detailing
the omissions or inadequacies that led to the decision not to
accept the application, will issue within 15 days of receipt
of the original IDE. The letter will clearly state whether a
complete, new application must be submitted or specify which
portion of the application must be provided if the sponsor
wishes to pursue the investigation.
2. Industry Inquires
In the event that the sponsor has questions regarding the Refuse
to Accept letter, the sponsor may contact the appropriate Division
Director, via letter, telephone, or telefax, regarding the
decision.
3. Monitoring
The implementation of the IDE Refuse to Accept Procedures will be
reviewed by the Office of the Director, ODE, at regular intervals,
approximately every 90 days, to determine the number of incomplete
and/or inadequate applications not accepted, the consistency with
which the criteria are applied among and within divisions, further
necessary refinements to the process, and the overall impact on
the IDE program.
Effective Date
This memorandum effective immediately.
Susan Alpert, Ph.D., M.D.
Updated 5/7/1996
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