Blue Book Memos
Blue Book Memos - Continued Access to Investigational Devices During PMA Preparation and Review
July 15, 1996 (D96-1)
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.
IDE Guidance Memorandum - #D96-1
Office of Device Evaluation (HFZ-400)
Continued Access to Investigational Devices During
PMA Preparation and Review
ODE Review Staff
Purpose
The purpose of this memorandum is to adopt an official policy on the
continued access to investigational devices while a marketing application
is being prepared or reviewed.
Policy
On May 10, 1995, the Office of Device Evaluation issued a memorandum to
the ODE review staff explaining the conditions under which an
investigational device may be made available during the preparation or
review of a marketing application.
Under this policy, a sponsor may propose to conduct an "extended"
clinical trial if: 1) there is a public health need for the device and
2) there is preliminary evidence that the device is likely to be
effective and no significant safety concerns have been identified for the
proposed indication.
A copy of the original memorandum dated May 10, 1995 is attached for
reference and to provide further elaboration on this policy.
Effective Date
This memorandum is effective immediately.
Susan Alpert, Ph.D., M.D.
Attachment
IDE Memorandum #D96-1
Attachment - Page 1
Date: May 10, 1995
From: Director, Office of Device Evaluation (ODE)
Subject: Investigational Devices Exemption (IDE) Policy Which
Permits Continued Access to Investigational Devices While a
Marketing Application is Being Prepared or Reviewed
To: ODE Review Staff
It has recently been brought to my attention that the Office policy
regarding continued availability of investigational devices during the
period between completion of the clinical study and approval of the
marketing application requires clarification. In the near future, a blue
book memorandum will be developed which will provide specific guidance on
this topic. In the mean time, however, ODE's reviewing divisions should
use the general principles presented below as a guideline for developing
appropriate criteria for their own use.
ODE has traditionally permitted sponsors of clinical investigations to
continue to enroll subjects at a pre-determined rate while a marketing
application is being prepared by the sponsor or reviewed by the Office if
there is: (1) a public health need for the device or (2) if there is
preliminary evidence that the device is likely to be effective and no
significant safety concerns have been identified for the proposed
indication. Such a policy is scientifically sound as it allows the
sponsors to collect additional safety and effectiveness data in support of
the marketing application or to address new questions regarding the
investigational device during this intervening period. This approach is
also administratively appropriate as the preparation and review times for a
marketing application can be lengthy; and thus, it could be contrary to the
public health to prevent access to these potentially safe and effective new
devices during a lengthy evaluation period.
Once a preliminary review of the data (IDE, 510(k), or PMA) indicates that
there is evidence of safety and effectiveness, a sponsor may propose to
conduct an "extended" clinical investigation of the device. An extended
investigation may be conducted for a number of reasons. For example, a
sponsor may propose an extended trial for the same indication for use as
studied under the IDE and use the same study protocol to provide
confirmatory evidence of safety and effectiveness. A modified clinical
protocol may be used to better define safety and effectiveness in a
subpopulation, to support new indications for use or new modalities of use
for the device, to identify and quantify adverse reactions, to address
long-term effects of the device, to support additional labeling claims, or
to confirm that minor changes made to the device design or to the
conditions under which the device will ultimately be used do not
substantially impact safety and effectiveness.
IDE Memorandum - #D96-1
Attachment - Page 2
A request for an extended investigation must be submitted by the sponsor of
the IDE in writing as a supplement to the IDE. When reviewing a request
for an extended investigation from the sponsor, the sponsor's justification
for the extension, the preliminary safety and effectiveness data (IDE,
510(k) or PMA), the risks posed by the device, the proposed rate of
continued enrollment, the proposed objectives for the extended study, the
sponsor's progress toward submission of the marketing application, and/or
ODE's progress in the review of the marketing application should be
considered. All of these factors may influence ODE's decision to approve,
approve with modifications, or disapprove the proposed protocol for this
intervening period between completion of the core clinical investigation
and approval of the marketing application. The above factors should also
be considered by ODE when deciding upon an appropriate rate of enrollment,
number of investigators, and number of investigational sites for the study
during this stage of product development. Finally, a sponsor who has been
negligent in his monitoring responsibilities or who has exhibited other
unresolved compliance problems would not be permitted to participate in an
extended investigation.
An investigation conducted under the provisions of this policy must still
be conducted in accordance with the IDE, IRB, and Informed Consent
regulations (21 CFR 812, 56, and 50, respectively). FDA may withdraw
approval for the extended investigation for any of the reasons identified
in 21 CFR 812.30 (b), if the device is being commercialized, or if there is
not satisfactory progression towards submission of the marketing
application or towards approval of the marketing application. As in the
withdrawal of approval of an IDE, however, ODE must make every attempt to
resolve the issue(s) with the sponsor, must notify the sponsor in writing
of the issue(s), and must notify the IDE Staff and the Director's office
before proceeding with this course of action.
Effective Date
This memorandum is effective immediately.
/s/
__________________________
Susan Alpert, Ph.D., M.D.
Updated 11/18/1996
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