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.

Safe Medical Devices Act of 1989 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to require medical device user facilities to inform the Secretary of Health and Human Services and the manufacturer whenever they believe a medical device could have contributed to a death, illness, or injury, or has or will seriously malfunction. Defines "medical device user facility" (MDUF) to mean a hospital, ambulatory surgical facility, outpatient diagnostic or treatment facility which is not a physician's office, or a nursing home. Prohibits retaliation against MDUF personnel or practitioners who file reports. Gives U.S. district courts jurisdiction over civil actions for damages for retaliation. Establishes civil penalties against MDUFs for knowing failure to report.

Directs the Secretary to: (1) conduct a study of compliance with these provisions and prevents them from going into effect if the Secretary finds substantial compliance; and (2) conduct education and information programs for MDUFs respecting these requirements. Directs the Comptroller General to study compliance by MDUFs and the actions taken by the manufacturers in response to reports.

Directs the Secretary to amend Federal regulations to require distributors of medical devices to establish and maintain records and make reports under these provisions. Amends the FDCA to require distributors to submit copies of certain reports to the manufacturer of the device for which the report was made.

Requires each manufacturer, importer, and distributor required by existing law and regulations thereunder to make reports to submit to the Secretary annually a certification that: (1) they did not file any report because there were no events requiring a report; or (2) they did file reports of all events of which they had information.

Directs the Secretary to require: (1) every person who registers under existing provisions as a producer of drugs or devices and is engaged in the manufacture of a class III device to assign a model or other identification number to each device and to maintain certain records; and (2) every individual or entity which sells or uses a class III device to maintain certain records to ensure that patients who receive the devices can be provided the notification authorized by existing provisions.

Amends the FDCA to add the failure or refusal to submit any report required by or under the Act to the list of prohibited acts.

Allows a device, for purposes of provisions relating to classification of devices and relating to premarket approval, to be considered substantially equivalent to another device only if the Secretary by order finds it has the same intended use and: (1) the same technological characteristics; or (2) different technological characteristics, in which case it must be demonstrated that it is as safe and effective as comparable devices which are currently being sold in interstate commerce. Adds such order to the list of information to be made available to the public.

Requires a manufacturer, in certain circumstances, to certify that it has conducted a search of all information known to the manufacturer and all published information respecting a substantially equivalent device and has included in a specified report a description of and a citation to all adverse safety and effectiveness data. Allows the Secretary to require the manufacturer to submit the adverse data described in the report.

Directs the Secretary to: (1) require manufacturers of devices which are subject to reclassification under this Act to submit a description of and a citation to any adverse safety or effectiveness information, and authorizes the Secretary to require the submission of the described or cited data; and (2) reclassify certain class III devices as class I, class II, or class III, using the criteria in existing classification provisions.

Adds the failure or refusal to furnish certain information as required by this Act to the list of prohibited acts.

Amends provisions establishing classes of devices to allow class II, which currently involves performance standards, to involve special controls including, but not limited to, performance standards.

Authorizes the Secretary to change the classification of a device from class III to class II or class I if the Secretary determines that the controls at each of those levels would provide reasonable assurance of the safety and effectiveness of the device.

Revises the procedures for establishing performance standards for devices.

Removes the non-state-of-the-art design and manufacture basis for repair, replacement, or refund remedies.

Directs the Secretary to require a manufacturer, importer, or distributor of a device to report any removal or field repair of a device undertaken to eliminate a health risk or to remedy a violation of this Act. Requires recordkeeping of repairs or removals which are not required to be reported.

Requires the Secretary to support education and training activities to minimize the exposure of people to health hazards associated with devices.

Requires the effectiveness of a device to be determined on the basis of well-controlled investigations irrespective of the sponsor of the investigations. (Current law requires well-controlled investigations, but makes no reference to the sponsor.)

Allows the Secretary, for good cause shown, to refer a classifying petition to a classification panel. (Current law requires the Secretary to refer a petition to a panel.)

Revises procedures for: (1) establishing and amending performance standards; (2) processing premarket approval applications; (3) banning devices; and (4) processing petitions, under specified transitional provisions, for classifications of a device in class I or II.

Transfers provisions of the Public Health Service Act relating to electronic product radiation control to the FDCA.

Provides that the regulation of medical devices used to deliver electro-convulsive therapy is not affected by this Act.