HHS Publication FDA 97-4179
The Center for Devices and Radiological Health (CDRH) of the Food
and Drug Administration (FDA), develops and implements national
programs to protect the public health in the fields of medical
devices and radiological health. These programs are intended to
assure the safety, effectiveness, and proper labeling of medical
devices, to control unnecessary human exposure to potentially
hazardous ionizing and non-ionizing radiation, and to assure the
safe, efficacious use of such radiation.
The Center publishes the results of its work in scientific journals
and in its own technical reports. These reports disseminate results
of CDRH and contractor projects. They are sold by the Government
Printing Office and/or the National Technical Information Service.
Many are available via the FDA home page on the World Wide Web
at: http://www.fda.gov.
We welcome your comments and requests for further information.
D. Bruce Burlington, M.D.
Director
Center for Devices and
Radiological Health
The Medical Device Amendments of 1976 mandated the establishment of "an
identifiable office to provide technical and other nonfinancial assistance to
small manufacturers of medical devices to assist them in complying with the
requirements of the Federal Food, Drug, and Cosmetic Act." The Division
of Small Manufacturers Assistance (DSMA) in the Office of Communication, Education,
and Radiation Programs (OCER) was established to meet this requirement. DSMA
develops educational materials and sponsors workshops and conferences to provide
firms with a firsthand working knowledge of medical device requirements and
compliance policies.
This manual covers the Quality System regulation and the basic Good Manufacturing Practices (GMP) requirements that all manufacturers and distributors must consider when they plan to manufacture medical devices, including medical device kits, trays or packs, for distribution in the United States. Model procedures and sample forms are also included in the manual to assist manufacturers.
Adherence to the medical device Quality System regulation makes
good business sense and also serves public health aims -- two
very good reasons for the Food and Drug Administration (FDA) to
encourage compliance. However, a prerequisite to complying with
a regulation is a clear understanding of its content. Recognizing
this fact, the Division of Small Manufacturers Assistance (DSMA)
developed this manual to help manufacturers increase their knowledge
of medical device GMP requirements and FDA compliance policies.
DSMA also uses this manual at quality system workshops conducted
throughout the country.
The Quality System regulation outlines the minimum elements of a system for designing and producing a medical device. Manufacturers of medical devices commonly find that their quality needs are broader than these basic elements because of the additional need to meet company quality claims as required by paragraph 501(c) of the Federal Food, Drug, and Cosmetic (FD&C) Act and to meet customer needs and requirements.
The DSMA staff and the Office of Compliance (OC) in the Center
for Devices and Radiological Health (CDRH) provided valuable assistance
in preparing this manual.
For further information, contact the appropriate office within
CDRH or call DSMA at 800-638-2041, 301-443-6597 or FAX 301-443-8818.
Comments on this manual, related workshops, and other DSMA activities
are always welcome.
Lireka P. Joseph, Dr.P.H.
Director
Office of Health and Industry Programs
The Quality System (QS) regulation indicates the required end
result rather than specifically prescribing how a manufacturer
is to comply with this regulation. It is the responsibility of
the manufacturer to use good judgment when developing a quality
system which appropriately applies the QS regulation to their
specific products and operations. The manufacturer, not FDA, bears
overall responsibility for the production of high-quality products.
Nevertheless, FDA recognizes that manufacturers may benefit from
having guidance, model procedures, and sample forms that others
have developed or adopted in an effort to comply with the intent
of the regulation. The guidance in this manual includes discussion
on the entire QS regulation, plus it provides multiple examples
of procedures and forms which can be adopted and modified by manufacturers
as appropriate.
We have included a variety of model procedures and sample forms
in this manual. However, these are not meant to be official statements
of FDA policy. Rather, they represent a compilation of examples
that firms may find useful in understanding how some manufacturers
have successfully complied with QS and/or GMP requirements. Before
any model procedure or form is adopted into a quality system program,
the applicability and suitability to a particular device and manufacturing
operation should be carefully examined. This manual will assist
you in developing a quality system that meets the intent of the
FDA Quality System regulation.
FDA also recognizes the continuing need to use innovative approaches,
particularly in dealing with small businesses that could be unnecessarily
adversely affected by federal regulations. It is hoped that the
information in this manual will assist manufacturers in their
efforts to establish and maintain a quality system that enhances
business. The Office of Compliance at 301- 594-4692 or DSMA at
800-638-2041, FAX 301-443-8818, can be contacted for additional
assistance and information.
This manual can be purchased from the Superintendent of Documents,
U.S. Government Printing Office, Washington D.C. 20402, telephone
202-512-1800, and from the National Technical Information Service,
U.S. Department of Commerce, 5285 Port Royal Road, Springfield,
VA 22161, telephone 703-487-4650. This manual is also available
to all manufacturers through the World Wide Web at: http://www.fda.gov.
Sincerely yours,
John F. Stigi
Director
Division of Small Manufacturers Assistance
A. Lowery, J. Strojny, and J. Puleo, Project Officers. Division
of Small Manufacturers Assistance, Office of Health and Industry
Programs. Medical Device Quality Systems Manual: A Small Entity
Compliance Guide. HHS Publication FDA 97-4179 (December 1996).
This manual covers requirements of the Quality System regulation
that manufacturers of medical devices must consider when they
design devices, or when they manufacture, contract manufacture,
remanufacture, process, repack, or relabel finished medical devices
intended to be commercially distributed. The manual contains articles
that explain the various good manufacturing practices (GMP) requirements
such as design controls, process validation, calibration, device
master records, component control, etc., along with related topics
such as labeling. It also contains examples of forms, procedures,
decals, etc. Manufacturers may use this guidance when developing
their quality system.
This manual incorporates changes required by the Safe Medical
Devices Act of 1990 and the Medical Device Amendments of 1992.
This manual is an update of HHS publication FDA 91-4179, "Medical
Device Good Manufacturing Practices Manual, Fifth Edition."
This manual is used in the Division of Small Manufacturers Assistance
(DSMA) medical device workshops.
The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department. The educational information in this manual is not an official statement binding FDA. |
Although this guidance document does not create or confer any rights for or on any person and does not operate to bind FDA or the public, it does represent the agency's current thinking on guidance for quality systems. Where this document reiterates a requirement imposed by statute or regulation, the force and effect as law of the requirement is not changed in any way by virtue of its inclusion in this document. |
Updated January 1, 1997
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