Library of Congress Summary
The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.
10/26/1990--Conference report filed in House.
Safe Medical Devices Act of 1990 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to require medical device user facilities to report to the Secretary of Health and Human Services, the manufacturer, or both whenever they believe there is a probability that a medical device has caused or contributed to a death, illness, or injury.
Defines a medical "device user facility" (DUF) to mean a hospital, ambulatory surgical facility, nursing home, or outpatient treatment facility which is not a physician's office.
Prohibits the Secretary, subject to exception, from disclosing the identity of a DUF which makes a report.
Prohibits a report from being used in any civil action involving private parties unless the report maker had knowledge of the falsity of the report.
Requires the Comptroller General to study compliance by DUFs with these reporting requirements, actions taken by manufacturers in response to reports, and the cost effectiveness of the requirements and their implementation.
Requires each manufacturer, importer, and distributor to annually certify to the Secretary the number of reports it filed, or that it filed no reports.
Requires manufacturers of devices to adopt a method of device tracking.
Requires a manufacturer of certain devices which are substantially equivalent to a class III device to certify to the Secretary that the manufacturer has conducted a search of all available information and has included in the report under specified provisions a summary of and a citation to all adverse safety and effectiveness data respecting the other device and respecting the device for which the report is being made.
Allows the Secretary to require the submission of the adverse safety and effectiveness data.
Provides, with regard to certain devices subject to revision of classification, for submission of a summary of and a citation to all available data, including adverse safety and effectiveness data which has not been previously submitted.
Prohibits the Secretary from retaining any daily wear soft or daily wear non-hydrophilic plastic contact lens in class III under the FDCA unless the Secretary finds it meets certain criteria.
Allows certain devices to be in Class I if insufficient information exists to establish special controls (currently, to establish a performance standard).
Includes in Class II devices for which sufficient information exists to establish special controls (such as performance standards, postmarket surveillance, and patient registries) to assure safety and effectiveness.
(Current law includes in Class II devices for which sufficient information exists to establish performance standards.) Allows the Secretary, as well as a manufacturer or importer, to initiate a reclassification.
Requires that special controls for Class II devices include performance standards if the Secretary determines that performance standards are necessary to provide reasonable assurance of safety and effectiveness.
Modifies procedures for the establishment, amendment, or revocation of performance standards.
Requires a manufacturer, importer, or distributor of a device to report to the Secretary any correction or removal of a device, other than for routine servicing, if the action was undertaken to:
(1) reduce a risk to health; or
(2) remedy a violation of this Act caused by the device which may present a risk to health.
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 order the appropriate person (including manufacturers, importers, distributors, or retailers) to cease distribution and to notify health professionals and DUFs of the order.
Provides for recall of devices, specifying that a recall order shall:
(1) not include recall from individuals;
(2) not include recall from DUFs if the risk of recalling presents a greater health risk than the health risk of not recalling the device from use; and
(3) provide for notice to individuals subject to the risks associated with the use of the device.
Allows the Secretary to temporarily suspend, as well as to withdraw, approval of an application for premarket approval.
Requires manufacturers to conduct postmarket surveillance for certain devices first introduced after January 1, 1991.
Requires approval by the Secretary of a protocol for the surveillance.
Allows the use for certain purposes of premarket approval data one year after the original application for the fourth device of a kind.
Deems devices to be of a kind if they use the same technologies, have the same principles of operation, and are intended for the same use or uses.
Considers a device to be substantially equivalent if it has the same intended use as an earlier device and:
(1) has the same technological characteristics; or
(2) the application contains information that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and efficacy than the earlier device.
Allows the Secretary to grant an exemption from certain effectiveness requirements for a device for which the Secretary finds that:
(1) it is designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals;
(2) the device would not be available without the exemption and no comparable device is available; and
(3) the probable benefit outweighs the risk of injury or illness from use of the device, taking into account probable risks and benefits of other available devices or alternative forms of treatment.
Prohibits selling an exempted device for an amount that exceeds the costs of research and development, fabrication, and distribution of the device.
Allows such devices to be used only in facilities with a local institutional review committee which has approved the use.
Establishes in the Department of Health and Human Services the Office of International Relations. Authorizes the Secretary to enter into agreements with foreign countries to facilitate commerce in devices between the United States and those countries consistent with this Act. Directs the Secretary to designate a component of the Food and Drug Administration to regulate products that are a combination of a drug, device, or biological product.
Requires that the premarket review of products in which the primary mode of action, as determined by the Secretary, 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.
Provide for civil penalties for violation of a requirement of the FDCA relating to devices.
Directs the Secretary to conduct a study on whether there has been substantial compliance with requirements of this Act regarding reporting of death, injury, or illness associated with a medical device.
Makes the civil penalty provisions effective only if the Secretary fails to submit the report by 48 months after enactment of this Act of if the report shows there has not been substantial compliance.
Authorizes (currently, requires) the Secretary, for good cause (currently, no reference to good cause), to refer a petition for a classification change that does not contain any deficiency to a classification panel.
Modifies requirements regarding:
(1) referral of a regulation for the establishment, amendment, or revocation of a performance standard to an advisory panel; and
(2) referral of an application for premarket approval to a classification panel; and
(3) procedures for designating a device as banned.
Adds pre-production design validation to the stages in which the Secretary may require a device to conform to current good manufacturing practice.
Transfers provisions of the Public Health Service Act relating to electronic product radiation control to the FDCA.