Medical Device Improvements Act of 1988

(Measure passed House, amended)

Medical Device Improvements Act of 1988 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to require any hospital, ambulatory surgical facility, or nursing home which receives or otherwise becomes aware of information that reasonably suggests that a medical device may have caused or contributed to the death of a patient to promptly report the information to the Secretary of Health and Human Services (HHS) and, if the identity of the manufacturer is known, to the manufacturer of the device. Requires, whenever a facility becomes aware of information suggesting that a medical device may have caused a life-threatening illness or injury, or when a medical device malfunctions in a way likely to cause death or serious illness, that the information be reported to the manufacturer of the device. Provides that if the identity of the manufacturer is undeterminable, the facility must report the information to the Secretary.

Requires facilities to submit to the Secretary quarterly summaries of the reports made to manufacturers respecting device malfunctions. Requires summaries to contain information for the purpose of determining reporting compliance by manufacturers.

Treats facilities as having received or otherwise become aware of information with respect to a medical device when an employee becomes aware of such information in the course of duties.

Limits disclosure of the identity of a facility making a report, the device which was the subject of a report, or the device manufacturer.

Shields individuals and entities from liability in private civil actions with respect to the content of reports, unless the individual or entity had knowledge of the falsity of the information. Prohibits a report, or the fact that such a report has been made, from being admitted into evidence or otherwise used in an action other than one brought to enforce the FDCA.

Prohibits facilities from taking any adverse personnel action against an employee or practitioner for making a report.

Imposes civil penalties on facilities failing to make required reports.

Directs the Secretary to conduct a study of compliance with the provisions of this Act and of the cost-effectiveness of the requirements and their implementation and any recommendations for improving the requirements. Requires that the results be reported to the Congress.

Provides that the penalty provisions of this Act may not apply to certain facilities, depending on whether or not there has been substantial compliance with this Act.

Directs the Secretary to conduct education and information programs for a one-year period for facilities and manufacturers of devices regarding the requirements of this Act.

Directs the Comptroller General to: (1) conduct a study three years after enactment of this Act of compliance by facilities, of actions taken by manufacturers in response to reports made under this Act, and of the cost effectiveness of such requirements; and (2) submit a report to specified congressional committees.

Directs the Secretary to amend certain regulations to require distributors of medical devices to establish and maintain records and make reports under the FDCA. Requires reporting distributors to submit copies to device manufacturers.

Authorizes the Secretary to waive certain requirements in applications for premarket approval of class III devices in certain circumstances.

Directs the Secretary: (1) upon determining that a requirement has been met for a device, to make that determination for all devices of the same type in the absence of good cause that such determination should not be made; and (2) to include in the consumer safety and effectiveness information a statement describing the basis upon which the determination was made.

Defines "substantial equivalence" for purposes of classifying devices, as requiring: (1) the same intended use and the same technological characteristics; or (2) the same intended use but different technological characteristics and evidence demonstrating the device is as safe and effective as comparable devices currently sold in interstate commerce. Provides that technological characteristics shall be considered different from those of another device if there is a significant change in materials, design, energy source, or other features.

Directs the Secretary to promulgate regulations requiring device manufacturers to prepare a detailed summary of any clinical data (including adverse health effects) required by the Secretary in making the determination that the device is substantially equivalent to another device.

Requires certain certifications by a manufacturer who reports to the Secretary that a device is not a class III device because it is substantially equivalent to another device meeting certain criteria.

Directs the Secretary, within five years, to: (1) require manufacturers of devices which are subject to revision of classification to submit a description of and citation to any known adverse safety or effectiveness information respecting the devices which has not previously been submitted; and (2) require manufacturers to submit adverse safety and effectiveness data.

Requires the Secretary to publish a notice for each class III device which was commercially distributed before the date of the enactment of this Act, and for which no final regulation has been promulgated, revising the classification into class I unless the notice requires the device to remain in class III or revises the classification so that it is classified into class II. Sets forth criteria for the Secretary to apply in determining whether to revise the classification of a device or to require a device to remain in class III. Sets forth publication, notice, comment, and petition provisions regarding classification revisions by the Secretary. Provides for judicial review of classifications.

Revises existing standards to designate as class II devices those devices for which it can be determined whether or not a performance standard is appropriate rather than requiring a performance standard as under current law.

Revises the standard for classification of class III devices (devices requiring premarket approval) to provide that a device must be so classified if insufficient information exists to determine that class I or class II controls will assure safety and effectiveness.

Revises the evidence required for reclassification of a class III device.

Revises procedures for establishing performance standards for devices.

Directs the Secretary to file a civil action upon determining that: (1) a device intended for human use presents an unreasonable risk of substantial harm to the public health; (2) there are reasonable grounds to believe that the risk was not caused by failure to exercise due care, and that the device was properly designed and manufactured with reference to the state of the art; (3) notification would not, by itself, be sufficient to eliminate such risk; and (4) the person responsible for the unreasonable risk has not submitted to the Secretary a satisfactory plan, or has made insufficient progress in carrying out a plan to eliminate the risk.

Provides that no device shall be considered to present an unreasonable risk of substantial harm to the public health solely on the basis that it was designed and manufactured subsequent to the device and incorporated safer features.

Directs that any order entered in a civil action requiring repair or replacement of a device or providing a refund shall be subject to a reasonable allowance for use unless the device was intended to be implanted into the human body.

Permits an individual availing himself of a remedy under this Act to be charged a reasonable allowance for use. Specifies that for purposes of an order issued under this Act, "expenses actually incurred" does not include any expense covered under a health insurance policy or health benefit plan.

Provides that field repairs or removals of devices (recalls) must be reported to the Secretary if they are taken to eliminate a risk to health or to remedy a violation of the Federal Food, Drug, and Cosmetic Act.

Provides that requirements applicable to manufacturers are extended to those who remanufacture medical devices. Excludes routine service from the definition of remanufacture.

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

Makes it discretionary rather than mandatory to refer petitions for classifying new devices in class I or class II to a panel. Revises other panel procedures.

Removes the requirement that the Secretary afford all interested persons an informal hearing before a performance standard may be amended.

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.