ANSWERS 10/4/1996
T96-66 Sharon Snider October 4, 1996 (301) 443-3285 FDA STRENGTHENS STANDARDS FOR NEW MEDICAL DEVICES The Food and Drug Administration today announced new changes to manufacturing quality standards for medium and high risk medical devices to make them safer and more effective, and to align the United States with emerging regulatory requirements worldwide. Manufacturers must now incorporate a set of checks and balances in their design processes to assure a safe, effective finished product. Such pre-production design controls are already in use in automotive, aerospace and most Department of Defense industries. Design controls will save lives and will greatly reduce the risks from unrecognized design flaws. For example, if a manufacturer were planning to design a new defibrillator for use in hospitals and ambulances to restart the heart in emergencies, designers would have to consider all aspects of use in both settings, not just in the hospital. They would have to consider storage temperatures in the ambulance, road shock and vibration, two-way radio interference, electrical noise generated by the siren and many other factors. The design would have to be reviewed throughout development to make sure all requirements were being met. -More- Page 2, T96-66, Standards for New Medical Devices Or, if a manufacturer were planning to design a glucose monitor for use by diabetics to monitor their blood glucose at home, designers would have to consider special circumstances that might arise, such as use by diabetics who have diabetic eye disease, other persons in the home and medical personnel. They would also have to consider the effects on the monitor from other electrical and electronic products in the home such as computers, televisions, radios, telephones and other medical devices. Under design controls, manufacturers must establish performance requirements for a device before production, ensure that device components are compatible with each other, select adequate packaging materials, and where appropriate do a risk analysis. The new standards, which will be published in the Federal Register Monday, also include purchasing and manufacturer servicing controls and clarify requirements of the current Good Manufacturing Practice (GMP) regulation. A Government Accounting Office (GAO) review of medical device recalls during a six-year period in the 1980s found that about 44 percent of quality problems were attributable to errors or deficiencies in the device design and could have been prevented with proper design controls. Design-related defects have been found in such critical products as heart valves, catheters, defibrillators, pacemakers, ventilators, patient chair lifts and laboratory tests. -More- Page 3, T96-66, Standards for New Medical Devices The new Quality System regulation will make standards for American medical devices consistent with quality system requirements worldwide, thereby meeting an important goal of global harmonization. The new standards closely follow the international standard, ISO 9001, and fulfill a mandate of the Safe Medical Devices Act of 1990 to harmonize these requirements. FDA's move to revise the GMP regulation to include design controls was endorsed by the GAO in a 1993 report which commended the agency for taking steps to advance international harmonization and competition without compromising public health goals. The new Quality System regulation incorporate changes suggested by the medical device industry in response to a proposed rule published in November 1993 and a working draft published in July 1995. The changes, which were endorsed by FDA's GMP Advisory Committee in September 1995, give manufacturers greater flexibility in achieving the quality requirements. The new regulation describes the objectives of each control tool but allows manufacturers to develop their own methods for implementing them. The regulation does not cover people who service and refurbish medical devices outside the control of the original manufacturer. Servicers and refurbishers will be addressed in a separate rulemaking, with another opportunity for public comment. The Quality System regulation goes into effect in two stages. By June 1, 1997, all elements of the final Quality Systems rule become effective. However, to give the industry adequate transition time, the design control provisions will not be enforced until after June 1998--the same time equivalent design controls become mandatory in Europe. ####