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Compliance Program
Manual for FDA Staff

PART I

BACKGROUND

 This compliance program provides guidance to FDA field and center staffs for the inspections and administrative/enforcement activities related to the Quality System/Good Manufacturing Practices (QS/GMP) regulation (21 CFR Part 820), the Medical Device Reporting (MDR) regulation (21 CFR Part 803), the Medical Device Tracking regulation (21 CFR Part 821), the Corrections and Removals regulation (21 CFR Part 806), and the Registration and Listing regulation (21 CFR Part 807). This compliance program encompasses five regulations for inspecting medical device firms. Under the QS/GMP regulation, manufacturers are expected to control their products from "cradle to grave" meaning from design stage through post-market surveillance. Manufacturing processes, such as sterilization, are required to be implemented under appropriate controls. The MDR, Tracking, and Corrections and Removals regulations involve activities with which manufacturers and importers are required to comply after the devices are distributed. This compliance program provides specific guidance for each. It also requires coverage for the Registration & Listing regulation. NOTE: Contracting firms, unless they are contract sterilizers, design contractors or finished device manufacturers, are not generally subject to this compliance program. These operations are considered to be "vendor" operations, which are considered to be the responsibility of the manufacturer under 21 CFR 820.50.

A. THE QUALITY SYSTEM (QS/GMP) REGULATION

This compliance program provides an inspectional strategy designed to result in more efficient, focused and more harmonized (with the international community) QS/GMP inspections, which identifies and addresses issues of non-compliance. This new inspectional strategy is designed to compensate, in part, for the increasing strain on field resources while, at the same time, efficiently identifying non-compliance resulting in appropriate regulatory action when required. Revised enforcement criteria are provided in Part V, which tie to the new inspection approach.This inspectional strategy is called the Quality System Inspections Technique (QSIT). QSIT is based on a "top-down" inspection (21CFR Part 820) of a manufacturer’s quality system, using the seven subsystems of the Quality System regulation. The seven subsystems are: Management Controls, Design Controls, Corrective and Preventive Actions (CAPA), Production and Process Controls (P&PC), Facilities and Equipment Controls, Materials Controls, and Documents/Records/Change Controls. The "top-down" inspectional approach evaluates a firm’s overall "systems" capability for addressing quality, as opposed to a "bottom-up" approach, which starts by looking at one or more individual product problems that may point to a failure in the quality system. The strategy, outlined in this program, continues to place an emphasis on manufacturers’ responsibility and capability to monitor their compliance with QS/GMP requirements, and to take appropriate and timely correction of problems in their design, manufacturing, and quality management systems.

Important Note: "For Cause" inspections may still be conducted as the need arises. These inspections are generally more in-depth than the QSIT approach. (See Part III, page 8, for additional information regarding For Cause inspections.) These inspections should be directed toward finding the quality problems, tracing the root causes and assuring that appropriate corrective and preventive actions are initiated. For Cause inspections are usually initiated as the result of CDRH, ORA headquarters, Regional or District directives. They are most often initiated as a result of a serious health risk, which was brought to the attention of FDA. Immediate investigations/inspections are needed in these cases. These inspections can be conducted using the Guide to Inspections of Quality Systems, also called the QSIT Guide. However, more in-depth investigations are often needed in the CAPA area. The December 1997, Guide to Inspections of Medical Device Manufacturers is recommended when conducting For Cause inspections. NOTE: See Part III for additional information regarding the QSIT Guide.

  1. THE MDR REGULATION

The first Medical Device Reporting (MDR) regulation became final on December 13, 1984. As a result of changes mandated by the Safe Medical Devices Act (SMDA) of 1990, and the Medical Device Amendments of 1992, the 1984 MDR regulations (21 CFR 803 & 807) were revised and published on 12/11/95. The FDA Modernization Act of 1997 made additional changes to MDR and a revised MDR Regulation was proposed in May 1998. The final MDR regulation was published in the Federal Register on January 26, 2000. The latest version of MDR includes reporting requirements for manufacturers, user facilities, and importers, and will result in the revocation of 21 CFR Part 804, Medical Device Distributor Reporting. Please note that MDR reporting for medical device distributors (except importers) was revoked by the FDA Modernization Act of 1997. Distributors are, however, still required to maintain complaint records, per 21 CFR 803.18(d)(1-3). 21 CFR Part 803 requires manufacturers of medical devices, including in vitro diagnostic devices, to report to FDA whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices:
    1. May have caused or contributed to a death or serious injury or,
2. Has malfunctioned and that the device or any other device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. NOTE: Importers (initial distributors) of medical devices are subject to 21 CFR Part 803 published in the Federal Register on July 26, 2000, and effective March 27, 2000.

C. THE MEDICAL DEVICE TRACKING REGULATION

 Under the authority of section 519(e) of the Act, the agency may issue a written tracking "order" that tells a manufacturer to implement a tracking program that meets the requirements of 21 CFR Part 821. Devices subject to tracking may include those that are permanently implanted or life sustaining/life supporting devices that are used outside a device user facility. These devices are considered reasonably likely to cause serious adverse health consequences if they fail. The regulation is intended to ensure that in the event of a recall or safety alert, a tracked device can be traced by the manufacturer from the device manufacturing facility to the end user or patient.

D. THE CORRECTIONS AND REMOVAL REGULATION

 The Corrections and Removal (CAR) regulation requires manufacturers, and importers to report promptly to FDA any corrections or removals of devices being undertaken to reduce risk to health.

E. THE REGISTRATION AND LISTING REGULATION

The Registration and Listing regulation requires manufacturers and own label distributors to register and list their devices; and importers to register.