Comprehensive Medical Device Improvement Act of 1990

Summary

Comprehensive Medical Device Improvement Act of 1990 - Amends the Federal Food, Drug, and Cosmetic Act to require a person who proposes to market a medical device that the person claims is substantially equivalent to a class III marketed device to review published and unpublished data concerning the safety and effectiveness of the marketed device and the device proposed to be marketed. Amends provisions establishing classes of devices to allow class II, which currently involves performance standards, to involve additional controls to provide assurance of safety and effectiveness including, but not limited to, performance standards. Specifies that it is the Secretary of Health and Human Services who determines whether a device is excepted from provisions requiring that devices be initially classified in class III. Allows the Secretary to initiate reclassification of a device initially classified in class III. Directs the Secretary to: (1) require manufacturers of class III devices introduced before enactment of this Act to submit to the Secretary a citation to and summary of published and unpublished data concerning the safety and effectiveness of the device; (2) on the basis of criteria set by current law, information available when the device was initially classified, and any new information, reclassify the device to class II or class I, or continue the device in class III; and (3) establish a schedule for issuance of a regulation regarding submission of a premarket approval application for each device continued in class III. Directs the Secretary, if the Secretary determines that a performance standard is necessary to provide assurance of the safety and effectiveness of a class II device, to establish such a standard. (Current law, making no reference to any determination, authorizes the Secretary to establish such a standard.) Revises the procedures for establishment of performance standards. Allows the Secretary to suspend the approval of an application for premarket approval if the Secretary determines that continued distribution of the device will result in an unreasonable risk of substantial harm to the public health. Directs the Secretary, if the Secretary finds that a device presents an unreasonable risk of substantial harm to the public health, to issue a recall order including, subject to exception, withdrawal of devices from health care institutions and individuals. Requires distributors who submit required reports regarding a device to the Secretary to submit a copy of the reports to the manufacturer. Requires each manufacturer, importer, and distributor to annually certify to the Secretary that it has reported all events required to be reported, or that no such events have occurred. Defines "medical device user facility" (facility) to mean a hospital, nursing home, or ambulatory surgical facility. Requires a facility to inform the Secretary and, when known, the manufacturer when the facility becomes aware of information that reasonably suggests that a device may have contributed to the death of a patient. Requires the facility to inform the manufacturer, if identified (if not, the Secretary), of information reasonably suggesting that a device may have contributed to a serious illness or serious injury to a patient. Provides, with exceptions, for the confidentiality of information relating to such reports. Prohibits, except in an action to enforce these provisions, the introduction into evidence or other use in an action of the report or of the fact that the report was made. Authorizes the Secretary, for one year after enactment of this Act, to award grants for public education programs for facilities concerning these reporting requirements. Authorizes appropriations. Directs the Secretary to require a manufacturer, importer, or distributor to: (1) report to the Secretary any removal or field repair of a device, other than routine servicing, if undertaken to eliminate a risk to health or remedy a violation of this Act; and (2) keep a record of any field repair or removal, other than routine servicing, not required to be reported. Allows the Secretary, four years after premarket approval is granted, to use certain information in the premarket approval application to establish the safety and effectiveness of another device. Replaces provisions prohibiting traceability requirements unless necessary to protect the public health with provisions directing the Secretary to determine which devices should be subject to a requirement of labeling, coding, or other identification to ensure that the device may be traced from the place of manufacture or initial distribution to the ultimate user, from among devices that: (1) are for use in supporting life; (2) are for use in preventing impairment of health; or (3) present a potential unreasonable risk of illness or injury. Directs the Secretary to require the manufacturers, importers, and distributors of the devices to establish the means by which the devices will be traced to the ultimate user. Allows the Secretary to initiate a reclassification of certain new drugs classified as class III devices. Directs the Secretary to require the manufacturer to submit a description of and a citation to any adverse safety and effectiveness information not submitted under other provisions, and allows the Secretary to require the submission of the information itself. Prohibits the Secretary, notwithstanding any other portion of these provisions, from retaining any daily wear nonhydrophilic plastic contact lens in class III unless certain requirements are met. Prohibits a device from being found to be substantially equivalent to a device that has been removed from the market at the initiative of the Secretary or determined to be misbranded or adulterated by a judicial order. Directs the Secretary to: (1) promulgate regulations allowing a manufacturer to be required to prepare a summary of any clinical data required; and (2) make the summary available to the public after a determination of substantial equivalence. Directs the Secretary to require a manufacturer to conduct postmarket surveillance for specified types of devices, including those with respect to which the Secretary determines that surveillance is necessary to protect the public health or to evaluate the safety or effectiveness of the device. Allows the Secretary to determine the period of surveillance required. Prohibits imposing a surveillance period without a termination date. Requires the manufacturer of a device for which surveillance is required to contract with one or more academic medical centers to provide for any required monitoring of clinical experience. Allows the manufacturer to determine the number and identity of the centers, if any, that will perform surveillance, and the manner of surveillance. Adds references to design validation to provisions relating to adulterated devices, premarket approval, and control of devices. Directs the Secretary to require only one market clearance route for an article that constitutes a combination of a device, drug, or biological product.

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Documents

4 official files

• Reported to Senate (text)

  Reported to Senate · EN

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• Introduced in Senate (text)

  Introduced in Senate · EN

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• Reported to Senate with amendment(s)

  summary · EN · 9 October 1990

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• Introduced in Senate

  summary · EN · 4 August 1990

  Open at official source

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