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TECHNOLOGY ASSESSMENT STATUS EVALUATION
T E C H N O L O G Y ASSESSMENT STATUS E V A L U A T I O N DEVICE EVALUATION AND THE FOOD AND DRUG ADMINISTRATION
PROCESS
July, 1994
INTRODUCTION This report is developed in order to promote understanding of the device evaluation and review process by the Food and Drug Administration (FDA). In view of the recent increase in the number of available devices, there is increased awareness of the need for adequate review prior to marketing. The American Society for Gastrointestinal Endoscopy (ASGE) Technology Assessment Committee has developed a Status Report on Device Evaluation and the FDA Process to complement a series of status evaluation papers. BACKGROUND The United States is unique in that Federal law mandates the FDA to ensure that marketed medical devices are safe and effective. As there is unfamiliarity with the process of device evaluation and a perception by physicians and industry that this process for gastroenterological devices is frustratingly long, a statement reviewing the laws governing device approval and recommendations for ASGE involvement was considered appropriate. CHRONOLOGY AND LAWS GOVERNING FDA'S JURISDICTION In 1906, the Food and Drug Law provided definitions for adulterated and misbranded foods and drugs, and included provisions for criminal prosecution of persons responsible for violation. In 1938, the law was extended with the Food, Drug, and Cosmetic Act to include cosmetics and new drugs, requiring predistribution clearance for safety. V O L U M E 43, NO. 6, 1996
In 1976, the Medical Device Amendments separated the regulation of medical devices from the regulation of foods and drugs. These amendments require manufacturers of certain devices to provide assurances of their safety and effectiveness in a premarket approval application for the product. Most devices, however, need only show substantial equivalence to a legally marketed product through a pre-market notification submission prior to marketing. The 1990 Safe Medical Devices Act (SMDA) and the 1992 Medical Device Amendments require user facilities to report to the manufacturer and/or the FDA any information of which they become aware that reasonably suggests a medical device caused or con~ibuted to death, serious injury or illness of a patient of the user facility. Other requirements include device tracking by the manufacturer and post-marketing surveillance.
FDA S T R U C T U R E The FDA, directed by the Commissioner, is divided into centers, offices, divisions, and branches (Figure 1). Laparoscopes, endoscopes and their accessories are reviewed by the division which regulates devices for their intended use. Endoscopes which are introduced through the mouth, urethra or anus are reviewed within the Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices (DRAERD) by the Urology and Lithotripsy Devices Branch. Gastroenterology devices such as stents and manometry catheters are reviewed by the Gastroenterology and Renal Devices Branch of DRAERD. Disinfectants, sterilants, endoscope washers, and other types of sterilizers are reviewed by the Infection Control Devices Branch within the Division of General and Restorative Devices. GASTROINTESTINAL ENDOSCOPY
641
PROCESS
July, 1994
INTRODUCTION This report is developed in order to promote understanding of the device evaluation and review process by the Food and Drug Administration (FDA). In view of the recent increase in the number of available devices, there is increased awareness of the need for adequate review prior to marketing. The American Society for Gastrointestinal Endoscopy (ASGE) Technology Assessment Committee has developed a Status Report on Device Evaluation and the FDA Process to complement a series of status evaluation papers. BACKGROUND The United States is unique in that Federal law mandates the FDA to ensure that marketed medical devices are safe and effective. As there is unfamiliarity with the process of device evaluation and a perception by physicians and industry that this process for gastroenterological devices is frustratingly long, a statement reviewing the laws governing device approval and recommendations for ASGE involvement was considered appropriate. CHRONOLOGY AND LAWS GOVERNING FDA'S JURISDICTION In 1906, the Food and Drug Law provided definitions for adulterated and misbranded foods and drugs, and included provisions for criminal prosecution of persons responsible for violation. In 1938, the law was extended with the Food, Drug, and Cosmetic Act to include cosmetics and new drugs, requiring predistribution clearance for safety. V O L U M E 43, NO. 6, 1996
In 1976, the Medical Device Amendments separated the regulation of medical devices from the regulation of foods and drugs. These amendments require manufacturers of certain devices to provide assurances of their safety and effectiveness in a premarket approval application for the product. Most devices, however, need only show substantial equivalence to a legally marketed product through a pre-market notification submission prior to marketing. The 1990 Safe Medical Devices Act (SMDA) and the 1992 Medical Device Amendments require user facilities to report to the manufacturer and/or the FDA any information of which they become aware that reasonably suggests a medical device caused or con~ibuted to death, serious injury or illness of a patient of the user facility. Other requirements include device tracking by the manufacturer and post-marketing surveillance.
FDA S T R U C T U R E The FDA, directed by the Commissioner, is divided into centers, offices, divisions, and branches (Figure 1). Laparoscopes, endoscopes and their accessories are reviewed by the division which regulates devices for their intended use. Endoscopes which are introduced through the mouth, urethra or anus are reviewed within the Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices (DRAERD) by the Urology and Lithotripsy Devices Branch. Gastroenterology devices such as stents and manometry catheters are reviewed by the Gastroenterology and Renal Devices Branch of DRAERD. Disinfectants, sterilants, endoscope washers, and other types of sterilizers are reviewed by the Infection Control Devices Branch within the Division of General and Restorative Devices. GASTROINTESTINAL ENDOSCOPY
641