Cover page, Preface, Foreword - Medical Device Quality Systems Manual
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.
Center for Devices and
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.
Office of Health and Industry Programs
NOTE TO MANUFACTURERS OF MEDICAL DEVICES
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.
John F. Stigi
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 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.