CRYOLIFE INC
LETTER AGREEMENT
<DOCUMENT>
<TYPE>EX-10.44
<SEQUENCE>3
<FILENAME>cryolife10k123102ex1044.txt
<DESCRIPTION>LETTER AGREEMENT
<TEXT>
                                                                   EXHIBIT 10.44


[DHHS Logo]

DEPARTMENT OF HEALTH AND HUMAN SERVICES             Food and Drug Administration
--------------------------------------------------------------------------------
                                                    Atlanta District Office
                                                    60 Eighth Street, N.E.
                                                    Atlanta, GA  30309

                                                    Telephone: 404-253-1161
                                                    FAX: 404-253-1202


Steven G. Anderson
President and CEO
CryoLife, Inc.
1655 Roberts Blvd., NW
Kennesaw, GA 30144

Dear Mr. Anderson:

FDA and CryoLife  agree to extend the Agreement  dated  September 5, 2002,  copy
attached, for 45 more workings days ending on January 15, 2003.



/s/ Barbara A. Wood                           11/8/02
------------------------------------          ----------------------------------
Barbara A. Wood                               Date
Acting Director
Atlanta District Office





/s/ Steven G. Anderson                        11/8/02
------------------------------------          ----------------------------------
Steven G. Anderson                            Date
President and CEO CryoLife, Inc.




Attachment


<PAGE>


[DHHS Logo]

DEPARTMENT OF HEALTH AND HUMAN SERVICES             Food and Drug Administration
--------------------------------------------------------------------------------
                                                    Atlanta District Office
                                                    60 Eighth Street, N.E.
                                                    Atlanta, GA  30309

                                                    Telephone: 404-253-1161
                                                    FAX: 404-253-1202


Steven G. Anderson
President and CEO
CryoLife, Inc.
1655 Roberts Blvd., NW
Kennesaw, GA  30144

Dear Mr. Anderson:

This letter sets forth the entire agreement between CryoLife,  Inc.  (CryoLife),
and the Food and Drug  Administration  (FDA)  pertaining to the  disposition  of
certain human allograft  tissues,  which are subject to the August 13, 2002, FDA
Order for Retention, Recall, and/or Destruction. FDA and CryoLife agree that for
the next 45 working  days the tissues  specified  below may be  distributed  for
medically urgent use when all alternative  treatments have been exhausted or are
unavailable  and the conditions  specified  below have been  fulfilled.  FDA and
CryoLife  agree  that  only  the  following  human  allograft  tissues  will  be
distributed for the specified  medically urgent uses when alternative  therapies
are exhausted or unavailable:

     o    Non-valved  cardiac  conduits and patches  procured from the ascending
          aorta and pulmonary trunk and branch for use in neonates and pediatric
          patients.
     o    Saphenous   veins  used  for  peripheral   vascular   bypass  when  no
          alternative materials are available.
     o    Femoral  veins and arteries  used for dialysis  access when  synthetic
          access  device  becomes  infected  and when  external  bridging is not
          possible.
     o    Aorto-iliac artery for infected abdominal grafts:
          -    femoral veins and arteries for iliac extension.
     o    Saphenous  veins used for cardiac  bypass when no suitable  autologous
          tissue is available,  including internal mammary,  saphenous and other
          sites.

CryoLife  and  FDA  agree  that  the  specified  tissues  will be  released  for
distribution only after CryoLife completes the following steps:

1.   CryoLife  will  obtain a  prescription  from  the  surgeon  for the  tissue
     requested,  including its specific use. The  prescription  will include the
     surgeon's tissue  requirements  for the patient.  CryoLife will obtain from
     the surgeon a written  certification  that all other alternatives have been
     exhausted or are  unavailable  and that there is an urgent medical need for
     the tissue requested. For non-valved cardiac conduits and patches, CryoLife
     will  obtain  from each  pediatric  surgical  center,  in  addition  to the
     information  described  above, a request for the number of tissues that the
     center  estimates  it may use  during  the 45 day  period  for  which  this
     agreement is in effect.

2.   CryoLife will inform  surgeons  that  patients  should be notified that the
     tissue is  subject  to an FDA  recall,  that  there is a risk of  infection
     associated with these tissue implants,  and that  alternative,  approaches,



<PAGE>

     including  non-surgical,  should be exhausted or  unavailable  before using
     this  tissue.  CryoLife  will  obtain  from the  surgeon  either a  written
     acknowledgement that he has or will inform the patient of the above factors
     or, if this is contained in the informed consent,  a copy of that document.
     CryoLife  will  also  request  immediate  feedback  from  surgeons  of  any
     suspected infections after use of the tissue.

3.   CryoLife will contact Tissue and Organ Procurement  Organizations (TOPOs or
     OPOs) or other  facilities  that  procured the tissues  described  above to
     ascertain if microbial cultures were performed during or after procurement;
     if cultures  were  performed,  CryoLife  will obtain  documentation  of the
     results of that  testing.  Any  tissues  shown by these  tests to have been
     obtained from a donor whose tissue has cultured positive for microorganisms
     that have been associated  with infection,  or could be indicative of other
     microorganisms that have been associated with infections, including but not
     limited to,  Clostridium,  Candida and Escherichia coli (hereafter referred
     to as indicator organisms), will not be released. If there are no microbial
     records  available  from  the  procurement  site,   CryoLife  will  include
     additional labeling as described in paragraph number 6 below.

4.   CryoLife  will  perform a  retrospective  review  of its own  pre-packaging
     microbiological  testing  records  for  all  associated  donor  tissue.  If
     indicator microorganisms were isolated, the tissue will not be released.

5.   CryoLife will perform a search of its complaint files to ascertain if there
     are any complaints regarding infections for all associated donor tissue. If
     there are any such complaints  with regard to any associated  donor tissue,
     no tissue from the same donor will be released.

6.   CryoLife will provide the following  information in addition to its routine
     labeling  for  tissue  for  distribution:  in bold,  red caps,  in at least
     12-point, "BIOHAZARD: THIS TISSUE IS SUBJECT TO AN FDA ORDER FOR RECALL AND
     RETENTION  BASED ON FDA CONCERNS OVER THE VALIDATION OF THE METHODS USED TO
     PREVENT INFECTIOUS  DISEASE  CONTAMINATION AND  CROSS-CONTAMINATION.  IT IS
     BEING  RELEASED  DUE TO  URGENT  MEDICAL  NEED  AND IS ONLY FOR USE FOR THE
     INTENDED RECIPIENT."

     For tissue not  tested at  procurement,  CryoLife  will  further  label the
     tissue as,  "PROCUREMENT  CULTURES WERE NOT PERFORMED  PRIOR TO RECEIPT AND
     PROCESSING BY CRYOLIFE."

7.   CryoLife  will  document  and  maintain  records of its actions  under this
     agreement,  and make such records available for FDA review.  For non-valved
     cardiac  conduits  and patches,  CryoLife  will also track and document all
     tissue that is released pursuant to this agreement.

In addition,  CryoLife agrees to implement the following  interim  procedures to
help prevent infectious disease contamination or  cross-contamination  of tissue
during processing:

1.   CryoLife will perform pre-processing cultures on all incoming tissues prior
     to  antibiotics,  disinfectants,  or sterilizing  agents that would include
     either  100%  swabbing  or  10%   destructive   testing.   All  testing  of
     pre-processing  samples  will be performed  by a contract  laboratory  with
     validated  methods,   until  such  time  as  CryoLife's  test  methods  are
     adequately  validated.  Tissues contaminated with indicator  microorganisms
     that cannot be reliably  cleared by  CryoLife's  processing  system will be
     discarded.


<PAGE>

2.   CryoLife will perform  pre-packaging  cultures on all tissue made available
     for distribution,  using either 100% swabbing or 10% destructive  sterility
     testing.  All  testing of  pre-packaging  samples  will be  performed  by a
     contract  laboratory with validated methods,  until such time as CryoLife's
     test  methods  are  adequately  validated.  All tissue from a donor will be
     discarded  if  indicator  microorganisms  are found in any tissue from that
     donor.  In lieu of 100%  swabbing  or 10%  destructive  sterility  testing,
     CryoLife will demonstrate that the current practice of processing companion
     tissue for the purpose of pre-packaging  cultures adequately represents the
     tissue being processed through validation of this process.

3.   CryoLife will  establish a corrective  action plan within 30 days that will
     include steps to validate its processing  procedures to prevent  infectious
     disease contamination and  cross-contamination of tissue during processing,
     including any  procedures to ensure that tissue  distributed by CryoLife is
     free, or reasonably  free,  from microbial  contamination.  This corrective
     action plan will include  specific and prompt  timeframes for completion of
     each step.  CryoLife agrees to engage a consultant/third  party reviewer to
     assist CryoLife in this validation.

4.   CryoLife agrees to replace tissue subject to the FDA Order and specified in
     this  agreement  with  tissue  that has been  processed  using the  interim
     procedures  above  as soon as  such  tissue  is  available.  As such  newly
     processed tissue becomes  available,  CryoLife agrees not to release tissue
     subject to the Order and this agreement  pending further  arrangements  for
     ensuring the proper disposition of such tissues.  Any further  arrangements
     must be agreed upon in writing between CryoLife and an authorized  official
     of the FDA.

This agreement  will remain in effect for forty-five  (45) working days from the
date of  signature by all parties.  FDA will review  records and other  relevant
information  related to CryoLife's  release of tissue under this  agreement,  as
well as the status of  CryoLife's  corrective  action plan,  before  determining
whether this agreement  should be renewed or modified to provide for any further
release of tissue subject to the Order of Retention, Recall, and/or Destruction.
FDA has  encouraged  CryoLife,  and CryoLife has agreed,  to implement  adequate
corrective  actions as rapidly as possible and to replace  tissue subject to the
Order with tissue  processed  subsequently  under the interim  procedures.  This
agreement  supplements  the August 13, 2002,  FDA Order for  Retention,  Recall,
and/or  Destruction and, except to the limited extent provided herein,  does not
in any way supercede, limit, or modify that Order.



/s/ Barbara A. Wood                           9/5/02
-------------------------------------         --------------------------
Barbara A. Wood                               Date
Acting Director
Atlanta District Office



/s/ Steven G. Anderson                        9/5/02
-------------------------------------         --------------------------
Steven G. Anderson                            Date
President and CEO CryoLife, Inc.






</TEXT>
</DOCUMENT>
