Summary: S.3006 — 101st Congress (1989-1990)All Information (Except Text)

Bill summaries are authored by CRS.

Shown Here:
Reported to Senate with amendment(s) (10/09/1990)

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device that the person claims is substantially equivalent to a class III marketed device to review published and unpublished data concerning the safety and effectiveness of the marketed device and the device proposed to be marketed.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devices introduced before enactment of this Act to submit to the Secretary a citation to and summary of published and unpublished data concerning the safety and effectiveness of the device; (2) on the basis of criteria set by current law, information available when the device was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 there is a reasonable probability that continued distribution of the device would cause serious, adverse health consequences or death.

Directs the Secretary, if the Secretary finds that there is a reasonable probability that a device would cause serious, adverse health consequences or death, to issue a recall order including, subject to exception, recall of devices from health care institutions. Directs the Secretary, in lieu of including individuals within the recall order, to order a notification to individuals or the health professionals who prescribed the device for the individuals. Requires a party to whom the recall order is issued to remedy the causes of the order and complete the recall. Provides for vacating of the recall order when those requirements have been fulfilled.

Requires distributors who submit required reports regarding a device to the Secretary to submit a copy of the reports to the manufacturer. Allows the Secretary to exempt classes of distributors from whom reports are not necessary for the protection of public health.

Requires each manufacturer, importer, and distributor to annually certify to the Secretary that it: (1) did not file a report; or (2) did file a certain number of reports.

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 has contributed to a death of a patient. Requires a facility to inform the manufacturer, if identified (if not, the Secretary), of information reasonably suggesting that a device has contributed to a serious illness or serious injury to a patient. Provides, with exceptions, for the confidentiality of information relating to such reports. Prohibits a report by a facility, personnel affiliated with the facility, or a physician who is not required to make a report from being admitted into evidence in any civil action involving private parties unless the person making the report had knowledge of the falsity of the report.

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 corrective action 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 corrective action or removal, other than routine servicing, not required to be reported.

Prohibits the Secretary from using information obtained under specified provisions as the basis for reclassification from class III to class II or class I (currently, from class III to class II).

Allows the Secretary, one year after the original application for the fourth device of a kind has been approved, to use certain information contained in an application for premarket approval. Allows the information to be used in approving devices, determining whether a product development protocol has been completed, establishing a performance standard, and reclassifying devices. Allows the Secretary to use, for specified purposes, information which has been made public from summaries of information about safety and effectiveness required by specified provisions.

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 permanent implants; (2) are for use in supporting life; 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 cititation 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 promulgate regulations prescribing procedures and conditions for an exemption for devices from the effectiveness requirements of specified provisions to permit the use of the devices by physicians in the treatment of rare diseases or conditions. Sets forth the conditions necessary to granting an exemption.

Directs the Secretary to require a manufacturer to conduct postmarket surveillance for specified types of devices, including those that present potential for serious risk to human health. Allows the Secretary to require postmarket surveillance if the Secretary determines that surveillance is necessary to protect the public health or 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 medical centers to provide for any required monitoring of clinical experience. Requires the manufacturer to determine, and obtain the Secretary's approval regarding, the number and identity of the centers that will perform surveillance, and the manner of surveillance.

Authorizes the Secretary to enter into agreements with foreign governments specifying that devices of either country manufactured in accordance with this Act are suitable for commercial distribution. Directs the Secretary to establish an Office of International Relations to plan and initiate programs for the recognition of such devices.

Directs the Secretary to designate a component of the Food and Drug Administration to regulate products that constitute a combination of a drug, device, or biological product, with premarket review of products in which the primary mode of action is that of a drug, that of a device, or that of a biological product being handled, respectively, by the persons who handle premarket review of drugs, devices, or biological products.

Prohibits the Secretary from approving an abbreviated application for new drug approval for ten years from the date of the approval of the listed drug, if the listed drug is anti-inflammatory, non-steriodal drug for which an application was submitted on or before March 29, 1982, and approved on or after October 31, 1988.

Amends Federal law to allow, in certain circumstances and notwithstanding specified other provisions, separate extension of the term of a patent for each of a group of products which were initially covered by one patent.