Resp Care
-
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). ⋯ 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.