[Federal Register Volume 60, Number 89 (Tuesday, May 9, 1995)]
[Notices]
[Pages 24635-24636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11415]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[FDA 225-94-6001]
Memorandum of Understanding Between the Food and Drug
Administration and the National Institute of Standards and Technology
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is providing notice of
a memorandum of understanding (MOU) between FDA and the National
Institute of Standards and Technology (NIST). The purpose of the MOU is
to collaborate in a program to develop standard reference materials
(SRM's) for a variety of biomaterials.
DATES: The agreement became effective February 14, 1994.
FOR FURTHER INFORMATION CONTACT: Sandy Cordes, Center for Devices and
Radiological Health (HFZ-20), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-3516.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which
states that all written agreements and memoranda of understanding
between FDA and others shall be published in the Federal Register, the
agency is publishing notice of this memorandum of understanding.
Dated: May 2, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
Memorandum of Understanding Between the National Institute of Standards
and Technology and the Food and Drug Administration, November 10, 1993
This memorandum of understanding (MOU) between the U.S.
Department of Commerce, National Institiute of Standards and
Technology (NIST) and the U.S. Department of Health and Human
Services, Food and Drug Administration (FDA) has been implemented to
facilitate the development of Standard Reference Materials (SRMs)
for materials used in medical implant applications. These materials
are commonly referred to as biomaterials.
Background
The National Institute of Standards and Technology has, as one
of its long-standing programs, the development of and marketing of
standard reference materials required for precision metrology in a
variety of applications. The Food and Drug Administration is
responsible for the regulation of medical devices made from
biomaterials. For many of these biomaterials, it has been determined
that subtle variations in chemical composition, trace element
content, crystalline structure or morphology, homogeneity, surface
topology and chemistry, and other material characteristics can
significantly alter the response of living tissue (i.e. the body) to
a material, either as an implant or by external contact. Thus the
availability of well-characterized reference materials for use in
generating baseline data on the biological performance of a
biomaterial, is essential.
Overview
The parties to this MOU will collaborate in a program to develop
(SRMs) for a variety of biomaterials. This collaboration will enable
NIST to enhance its activities in the biomedical area and increase
the utility of its SRM Program by addressing many critical
measurement needs in the assessment of biomaterials and medical
devices. The SRM Program at NIST will gain marketable SRMs for
biomaterials, an area in which NIST has had no previous products. At
the same time, [[Page 24636]] FDA will be assuring the availability
of well-characterized and uniform reference materials for the
comparative evaluation of new materials and devices. Evaluation of
biological performance data based on comparison to previously-used
and successful products will be both facilitated and improved.
Program Description
1. Selection of Materials--Candidate materials for SRM
development will be selected by mutual agreement between FDA and
NIST. The goal is to provide more realistic calibration standards
for the determination of physical, chemical, electrical, and
biological characteristics and/or properties of biomaterials.
Criteria for selection will include magnitude of the current or
potential utilization of the material in biomedical applications,
documented or reasonably foreseeable variability in response from
``off-the-shelf'' materials, criticality of the medical application,
cost of developing and potential market for the SRM, and others
mutually agreeable to both parties. At the time of selection, the
properties and characteristics to be controlled and measured will be
identified for each candidate SRM, as will be the proposed unit size
for distribution.
1.a An initial listing of candidate materials proposed at the
time of the initial agreement is given in Appendix A. Materials 1 &
2 were developed as a collaborative research iniative between FDA
and the American Dental Association (ADA) at both the FDA and NIST
laboratories. Material 1 has been provided to NIST for consideration
as an SRM. Material 2 which is currently being synthesized will be
provided on or about September 1993. No development work has been
done on materials 3-8.
2. Production of Materials--SRMs will be developed by any of
several laboratories, including NIST, FDA, NIH, commercial materials
suppliers, device manufacturers, academic institutions, and others.
A Material Safety Data Sheet (MSDS) will be required from the
supplier of all component materials and precursor/catalyst/ancillary
materials used in the production of SRMs developed under this MOU.
3. Certification--NIST will determine and specify what testing
must be performed and be the sole reviewer of the adequacy of data
used in the qualification of SRMs developed under this MOU. NIST
reserves the right to refuse distribution of materials if the data
are inadequate. All SRMs developed under this program will be
supplied with NIST certification for the properties/characteristics
deemed critical to the application.
4. Packaging--NIST will determine for each SRM the appropriate
source of packaging, either in-house or contract. Contract packagers
will seal the entire shipment in appropriate packages for shipment
to NIST.
5. Replenishment--NIST agrees to assume the responsibility for
replenishment of stocks for SRMs for which the market is at a level
that is financially beneficial to the Standard Reference Materials
Program.
6. Program Funding--FDA does not commit to providing any funding
or equipment to NIST or any selected SRM producer, or to providing
any laboratory effort in the development, characterization, or
production of SRMs being developed under this program.
Costs and Pricing
1. Initially, FDA will provide 900 grams of hydroxyapatite
(material 1, Appendix A) and 1000 grams of -Tricalcium
Phosphate (material 2, Appendix A) to NIST for use as an SRM. No
compensation to FDA is required for this initial supply of material.
Monies collected from the sale of the SRMs, which is over and above
the cost to produce, characterize and package the materials will be
used for additional SRM development.
2. NIST will have final authority over all matters pertaining to
pricing policy and for setting the price of individual SRMs.
General
1. SRMs developed in whole or in part by FDA prior to or under
this MOU, which remain unsold and are deemed by NIST, to be
technologically obsolete or otherwise no longer acceptable as SRMs,
may be removed from the NIST inventory without liability for
reimbursement to FDA by NIST. If FDA desires such products returned
to FDA, NIST will do so at FDA's expense after removal of SRM
certification.
2. The official representatives of the respective organizations
will be:
FDA: Director Division of Mechanics and Materials Science Office
of Science and Technology Center for Devices and Radiological Health
NIST: Chief Standard Reference Materials Program Office of
Measurement Services
Effective Dates
1. This MOU will become effective 30 days after being signed by
the appropriate authorities at both NIST and FDA. It will remain in
effect until terminated.
2. Either NIST or FDA may unilaterally terminate this MOU by
providing the other party written notice. It will become ineffective
60 days after such notice is delivered.
Approval/Acceptance
Signed:
D. Bruce Burlington, M.D.
Director, FDA/CDRH
Date: November 19, 1993
Approved:
Peter L.M. Heydemann, PhD.
Director, NIST/Technology Services
Date: January 14, 1994
Concur:
Thomas E. Gills
Chief, NIST/SRMP
Date: January 14, 1994
Appendix A
Purpose:
Development of a series of Calcium-Phosphorous based SRMs for
use in determining the composition of mixtures of calcium phosphate
based biomaterials or biomaterial coatings.
Proposed Calcium Phosphate Reference Biomaterials
1. Ca3(PO4)3OH......... Hydroxyapatite......... Ca/P=1.67
2. Ca3(PO4)2........... Tricalcium Phosphate Ca/P=1.50
().
3. Ca3(PO4)2........... Tricalcium Phosphate CA/P=1.50
(amorphous).
4. Ca4(PO4)2O.......... Tetracalcium Phosphate. CA/P=2.0
5. Ca3(PO4)2........... Tricalcium Phosphate CA/P=1.50
().
6. Ca2P2O7............. Calcium Pyrophosphate CA/P=1.0
(
).
7. CaO................. Calcium Oxide.......... NA
8. Ca10 (PO4) 5F2...... Fluorapatite........... CA/P=1.67
[FR Doc. 95-11415 Filed 5-8-95; 8:45 am]
BILLING CODE 4160-01-F
