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U.S. Department of Health and Human Services

Medical Devices

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Integrity of Data and Information Submitted to ODE #I91-2 (blue book memo) (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.

 

Integrity Memorandum G91-2

May 29, 1991

Integrity Memorandum #I91-2

Integrity of Data and Information Submitted to ODE

Purpose

The purpose of this Blue Book Memorandum is to specify the 
procedures to be followed by  the ODE staff if there is a 
question concerning the integrity of data and information 
contained in any PMA, IDE or 510(K) submission.  We want to 
encourage reviewers to be sensitive to the possibly of 
inaccurate, withheld or otherwise false data in submissions 
reviewed by ODE.  For example, the data may appear to be 
fabricated or the device design may suggest that the 
performance data are not feasible.

Procedures

If a reviewer has any suspicion concerning the integrity of 
data or information provided to ODE in connection with any 
official submission, the matter should be raised through 
supervisory channels to the Division Director level.  If the 
Division Director determines that it is necessary to verify 
the integrity of the data or information in the submission, 
the Division Director should notify the ODE Integrity 
Coordinator.  The Integrity Coordinator will discuss the 
matter with the appropriate Program Operations Staff Manager 
and, if further action is indicated, the matter will be 
directed to the ODE/OCS Coordinator to initiate an inspection 
of the person or persons responsible for the submission of 
the questionable data or information.  A submission that is 
referred to OCS for verification of the data will not be 
cleared until the integrity of the data is established.  

During the interim, the submission will be dealt with in 
accordance with established review procedures.  

The Integrity Coordinator will keep the Director, ODE, and 
the appropriate Division Directors informed of any 
inspections requested pursuant to these procedures.

Effective Date

These procedures are effective immediately.