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U.S. Department of Health and Human Services

Medical Devices

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Continued Access to Investigational Devices During PMA Preparation and Review July 15, 1996 (Blue Book Memo) (D96-1) (Text Only)

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 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.