Medical Devices

Toxicology Risk Assessment Committee #G89-1 (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.

General Program Memorandum G89-1

August 9, 1989

Toxicology Risk Assessment Committee

Please read the attached memorandum, endorsed by the Center Director, 
that proposed the establishment of a Center-wide Toxicology Risk 
Assessment Committee.

The primary purpose of this Committee will be to provide assessments of 
the potential toxic risks posed by products that are the subjects of 
marketing applications.  The Committee will be a key element in our 
review process for some of the applications that present difficult 
toxicology questions.  It will review the applications that are 
potentially problematic, that present sensitive, highly visible issues, 
or that may result in precedent-setting toxicology decisions.  The 
Committee will also review toxicology-related product approval guidance 

The attached memorandum describes the operating procedures to the 
extent that they have been developed.  Clearly, there remain some 
unanswered questions on selection criteria and policy issues, and the 
specific operating procedures are yet to be formulated.  However, 
because of the need to expedite the formation and operation of the 
Committee as a working body, it is our plan to actually begin and 
resolve many of the open procedural questions as the Committee 
proceeds.  The members of the initial Committee will formulate and 
propose specific procedures.

Listed below are the members of the initial Committee.

        Jerome Donlon, OD, ODE (Co-chair)
        Raju Kammula, DOED, ODE (Co-chair)
        William D. Galloway, DLS, OST
        Hoan-My Do Luu, DSRD, ODE
        Nirmal K. Mishara, DSRD, ODE
        Phyllis M. Silverman, DBS, OST
        Pei Sung, DMMS, OST

Dr. Jacobson and I selected the members whose names were among those 
submitted by Division Directors in ODE and OST.  Because of the nature 
of the expertise needed on the Committee, its members will come 
primarily from ODE and OST.  From time to time the chairperson and 
Committee members will rotate off the Committee, as new experts are 
identified and as there is a need to relieve those who have been 
serving for a period of time.  The Committee may call upon other staff 
in ODE and OST for assistance as necessary.

The establishment of the Toxicology Risk Assessment Committee is 
effective immediately.  ODE Division Directors are directed to identify 
applications that need its review and refer them to Dr. Donlon.


July 27, 1989

From:  Director, Office of Device Evaluation, CDRH
       Director, Office of Science and Technology, CDRH

Toxicology Risk Assessment Committee

To:  Director, Center for Devices and Radiological Health, FDA
     THROUGH:  Deputy Director, Center for Devices and
                 Radiological Health, FDA  /s/


We are writing to propose the establishment of a CDRH Toxicology Risk 
Assessment Committee and to briefly describe its purpose and operating 


As you know, the Office of Device evaluation (ODE) receives a wide 
variety of device marketing applications that pose questions of toxic 
risk to patients.  ODE attempts to review these with scientific rigor 
and consistency, although this is difficult because the toxicology 
expertise within ODE is dispersed among the divisions with some 
divisions lacking entirely in this scientific area.  Additional 
expertise exists within OST, but at present there is no established 
mechanism to bring the combined expertise of ODE and OST to bear on the 
"tough questions" that can arise in the toxicology area, and that often 
cut across ODE divisions.  For this reason, we propose the 
establishment of a central body of experts, drawn from both Officers 
which can be relied on as needed for expert toxic risk 

Operating Procedures

The primary function of the Committee would be to provide advice to the 
ODE operating divisions about toxicity data as a part of the product 
review process.  Its members would be asked to review IDE, 510(k) and 
PMA applications that present significant or precedent-setting 
toxicology questions, and to review toxicology-related product approval 
guidance documents.  The Committee members would be asked to render 
opinions, based on scientific assessments, of the potential toxic risks 
associated with the products under review; they would not be asked to 
make recommendations about product approvals.  The decisions on product 
approvals typically would continue to be made within the ODE divisions 
on the basis of an evaluation of all of the device's risks and 

The Committee would be composed of about seven people, primarily from 
ODE and OST, who are experts in toxicology, materials and statistics.  
We expect that the membership would rotate according to changing needs 
and the availability of experts.  ODE and OST would jointly determine 
the appropriate membership.

Also, the Committee would have the prerogative of calling upon other 
Center resources as needed.  Currently, some special government 
employee (SGE) toxicologists are cleared through Committee Management 
and are available as consultants to our advisory panels.  We plan to 
use these individuals as resources for the Toxicology Risk Assessment 
Committee.  The SGEs would advise this Committee in addition to 
reporting to the advisory panels.  We expect that in some cases the 
Committee would report on its risk assessments during the advisory 
panel meetings.

We propose that the Committee be managed by ODE.  The Committee would 
report directly to the Office of the ODE Director. However, on 
particular assignments it would respond to the Director of the ODE 
division seeking an assessment.  The Committee would write its own 
procedures and responsibilities, with the understanding that it must 
usually respond to requests for reviews within two to three weeks.  The 
risk assessments performed by the Committee will become part of the 
official files of the applications which are being reviewed.

The Toxicology risk Assessment Committee would not replace, nor would 
its function overlap with, the current PMS Toxicology Committee, which 
would presumably continue to serve as a forum for information exchange, 
problem identification, and Center-wide strategic planning.  It would, 
however, allow for the discontinuation of ODE's Toxicology Working 

We believe this Committee would be comparable to the Office of 
Compliance and Surveillance's (OCS's) Health Hazard Evaluation 
Committee, which draws its membership from other offices within the 
Center, and meets in response to specific needs to assess the risks 
caused by defective products, but is managed by OCS.

If you concur with this proposal ODE will issue the attached "blue 
book" policy (which will have this memorandum attached) to establish 
the Committee and to direct ODE Division Directors to identify 
applications which need review.



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