Health Device Legislation: An Overview of the Law and Its Impact on Respiratory Care

Abstract

The Medical Device Amendments of 1976 were intended to protect the public from unsafe and ineffective medical devices. The Food and Drug Administration (FDA) has general authority from this law to regulate medical devices but now must establish specific regulations to do so. In this process all devices are being classified in Class I (general controls), Class II (performance standards), or Class III (premarket approval). General controls impose relatively fewer restrictions, while premarket approval can require very strict laboratory and clinical testing. Classification panels have been grouping medical devices into these three classes. The Anesthesiology Device Classification Panel and the Pulmonary Function and Respiratory Therapy Subcommittee have recommended classifications for more than 200 types of devices. After comments from the public, the FDA will publish final device classifications, probably in 1979. The Medical Device Amendments also provide for release of safety and effectiveness data to the public, for tracing of devices in the field in case of recalls or problems, and for assistance to small manufacturers in complying with the law. The Medical Device Amendments should help to improve medical devices, but official regulations cannot accomplish everything. Users must also do their part by employing preventive maintenance and applying devices knowledgeably and safely.