Medical Device Safety Act

Medical Device Safety Act - Title I: Authority to Establish Standards - Authorizes the Secretary of Health, Education, and Welfare to establish safety standards for medical services, and to require unreasonably hazardous devices used in life-threatening situations to undergo a scientific review by the Department for safety and efficacy prior to their introduction into commerce or, if already in commerce, to determine whether they may continue to be marketed.

Authorizes the Secretary to promulgate a standard governing the performance or other characteristics of medical service whenever, in his judgment, a standard is necessary to reduce or eliminate unreasonable risk of illness or injury associated with exposure to or use of the device, and there are no other more practicable means to protect the public.

Requires the Secretary, prior to the initiation of a proceeding to promulgate a standard, and prior to publishing a proposed standard in the course of such proceeding, to consult with other Federal agencies concerned with settings and other nationally or internationally recognized standard-setting agencies or organizations, and to use the technical support of other Federal agencies.

Provides that the Secretary would initiate a proceeding to promulgate a device standard by publishing a notice which would invite interested persons to submit to the Secretary an existing standard or an offer to develop a standard.

Authorizes the Secretary to accept one or more of such offers, or to adopt an applicable existing standard, or in appropriate cases to develop a standard using the resources of the Department and other agencies, or by contracting with qualified non-governmental entities.

Provides that after publication of a proposed standard, interested persons may for good cause require the Secretary to refer the standard to an ad hoc independent advisory committee for recommendations with respect to any matter involved in the proposal which requires the exercise of scientific judgment.

Provides that the standard, when promulgated, would be subject to the judicial review provisions of the Administrative Procedure Act governing informal rule making.

Title II: Scientific Review of Certain Medical Devices - Authorizes the Secretary to subject a device, or a type or class of device, to scientific review for safety and efficacy if after consultation with an appropriate scientific panel, he found the device to be unreasonably hazardous when used, as intended, in life-threatening situations, and determined that there was no more practical means than such review to reduce the hazard.

Provides that when the principles of design and construction of any device or class of devices subject to scientific review evolve to the point at which the safety and efficacy of the device or such standards would be promulgated under the standard-setting authority set forth in this Act, and the scientific review requirement rescinded.

Provides for the exemption from scientific review of devices intended solely for investigational uses by qualified experts. States that devices on the market which are made subject to scientific review could continue to be marketed during the pendency of the review unless presenting a hazard requiring otherwise.

Provides that an application for scientific review would be referred by the Secretary to standing advisory scientific review panel for its recommendations.

States that an applicant may seek administrative review of the Secretary's denial of his application either through petitioning the Secretary to refer the application to an advisory committee of experts for its independent recommendations on the scientific issues involved, or in the alternative by obtaining a formal adjudicatory hearing. Provides for judicial review of a final order of the Secretary.

Title III: Notification of Defective Devices, Repair or Replacement - Provides that a manufacturer or importer would be required to notify the Secretary of any defects in devices produced, assembled, or imported by him if the defect is likely to create a substantial risk to the health or safety of any person, or of the failure of a device to comply with an applicable standard. States that unless exempted by the Secretary the manufacturer or importer would also be required to notify his dealers or distributors, and purchaser not for sale who are known to him, of the defect.

Provides that dealers or distributors who are notified of a defect by the manufacturer would be required to provide to the manufacturer or importer the names and addresses of each purchaser not for sale. Authorizes the Secretary to require the manufacturer or importer to remedy the defect, replace the device, or refund the purchase price.

Title IV: Requirement of Good Manufacturing Practice - Requires devices to be manufactured in accordance with current good manufacturing practice, as determined by the Secretary, to assure their safety and efficiency.

Title V: Reports and Records; Inspections and Registration of Establishments; Official Names - Requires the registration of device manufacturers and their continuing notification to the Secretary of the devices that they are producing and marketing. Authorizes the Secretary to establish official names for devices.

Requires manufacturers and distributors of devices subject to a standard or marketed under an approval of a scientific review application to maintain certain records relating to the safety and efficacy of the devices.

Gives the Secretary authority to inspect research data on devices, and to inspect research data on devices, and to extend to devices certain exemptions from inspection which are applicable to drugs.

Title VI: General Provisions - Establishes an Advisory Council on Devices to advise the Secretary with respect to matters of policy in carrying out the Acts provisions.

Authorizes the Secretary, directly or through contracts with public or private agencies, institutions and organizations and with individuals, to plan, conduct, coordinate, and support research and studies relating to devices.