Effect of the Medical Device Legislation on Automation in Medicine
The Medical Device Amendments, passed by Congress in May 1976, provided the Food and Drug Administration with substantial new authority to regulate new and existing medical devices. The term “medical device” is defined as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is — (1) recognized in the official National Formulary or USP, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolised for the achievement of any of its principal intended purposes.” All medical devices are classified into one of three regulatory categories. The classification category is designed to enable FDA to exert the amount of regulatory control appropriate to the degree of potential risk associated with the device. Class I devices are subject only to the general controls applicable to all devices. The general control provisions include good manufacturing practices. Class II devices are those for which performance standards will be established. Class III devices are those which must undergo scientific evaluation known as premarket approval. Class II and III devices are also subject to the general controls provisions. All preenactment devices, that is, all devices in commercial distribution before May 28, 1976, the enactment date of the Amendments, have been recommended for classification into one of these three categories. The device Amendments require FDA to establish advisory committees of experts to assist both in the classification of devices and in the review of Premarket Approval Applications. These advisory panels classified over 1,730 generic types of medical devices including automated and computer based equipment. The majority of computer based or computer assisted equipment has been recommended for classification in Class II (Performance Standards). In the pulmonary area, for example, the Anesthesiology Device Classification Panel recommended that pulmonary function test equipment be classified in category II (Performance Standards). Many of the pulmonary function analyzers are computer assisted and regulated as Class II medical devices. It is important to know that a new innovative device for testing parameters of lung functions, such as the lung water computer, may be declared non equivalent to a preenactment device and be required to undergo premarket approval.
KeywordsMedical Device Good Manufacturing Practice Advisory Panel Regulatory Category Investigational Device Exemption
Unable to display preview. Download preview PDF.