Medical Device Amendments

Medical Device Amendments - Title I: Classification of Medical Devices - Directs the Secretary of Health, Education, and Welfare, under the Federal Food, Drug, and Cosmetic Act, to appoint and organize separate classification panels of experts to review and classify devices into appropriate categories based on the safety and effectiveness of such devices.

Requires such panels to submit recommendations for the classification of devices into one of the three following categories: (1) exempt devices-those devices having a generally accepted medical use which are safe and effective when used according to instructions and warnings and which present a minimum risk; (2) devices subject to standards- those devices for which in order to reduce or eliminate unreasonable risk of illness or injury it is appropriate to establish reasonable standards to assure safety and effectiveness; and (3) devices subject to premarket scientific review-those devices for which inadequate evidence exists to assure safety and effectiveness.

Requires the Secretary to publish a report on the device classification scheme in the Federal Register and to allow for comment by interested persons.

Title II: Authority to Establish Standards - States that the standard is to relate to safety and effectiveness of devices, including consideration of specified factors.

Provides for periodic evaluation of the adequacy of standards.

Directs the Secretary to consult with other Federal agencies.

Requires the Secretary to publish in the Federal Register a notice that proceedings have been initiated to promulgate a device standard. Specifies the content of such notification.

Directs the Secretary to accept one or more offers to develop a proposed standard and to publish in the Federal Register names and addresses of persons whose offers are accepted and the terms of such offers.

Directs the Secretary to prescribe regulations governing development of proposed standards. Sets forth alternatives to the development of standards, including: (1) the use of existing standards; and (2) the development of standards by the Secretary.

Authorizes the Secretary to appoint independent advisory committees, to which could be referred any matters involving a proposed device standard, prior to or after its publication in the Federal Register. Prescribes the composition of such committees.

Requires that manufacturers of devices subject to standards shall assure the Secretary that such devices comply with any testing methods prescribed or that such device has been manufactured in accord with current good manufacturing practices designed to assure such compliance. Provides exemptions from such requirements for specified devices.

Title III: Scientific Review of Certain Medical Devices - Describes the circumstances under which scientific review premarket clearance of medical devices is required. States that scientific review of a device declared subject to such review may be otained by submitting to the Secretary an application containing specified information. Directs the Secretary to appoint standing advisory scientific panels to review device applications.

Directs the Secreary, after considering the panel's recommendations, either to: (1) approve the application; (2) advise the applicant that this application is not in approvable form and inform applicant of measures required to meet approval; or (3) deny approval if the device fails to meet specified criteria.

Sets forth the definition of "adequate scientific evidence". Provides for an opportunity for review of applications denied. Sets forth provisions regarding withdrawal of approval and suspension of approval.

Prescribes conditions pertaining to exemptions for clinical testing on humans, including: (1) submission of an outline of the plan of initial clinical testing; (2) submission of an adequate protocol for clinical testing together with a report of prior investigations, including tests on animals, adequate to justify the proposed testing; (3) obtaining of signed agreements from investigators that humans upon whom devices are to be used will be under their personal supervision; and (4) establishment and maintenance of records.

Requires the informed consent of human participants. Requires the consent agreement to contain no language through which the individual waives any legal rights or release the institution or its agents from liability for negligence. Defines "exceptional cases" as those in which consent is not feasible or where it would be contrary to the welfare or best interests of a particular subject, as determined by a physician in his professional judgment.

Provides for the exemption of custom devices, ordered by a physician to be made in a special way for individual patients, if the device meets enumerated requirements.

States that any person may petition the Secretary to establish a product development protocol for a particular custom device. Sets forth the grounds for revocation (or objection to notice of completion) of product development protocol.

Title IV: Notification of Defective Devices; Repair or Replacement - Provides that every person acquiring information showing a device produced, assembled, or imported by him to contain a defect likely to create a substantial risk to the public health or safety, or to be in non-compliance with an applicable standard shall be required to notify the Secretary of such defect or failure if the device has left control of the manufacturer. Specifies the content of such notification and enumerates the exemptions from such requirement. Sets forth the definition of "defect". Provides for the public disclosure of a defect and for the repair, replacement or refund of the cost of defective devices to the owner.

Title V: Requirement of Good Manufacturing Practice - Requires that a device, and the methods used in its manufacture, must conform to good manufacturing practice.

Title VI: Records and Reports; Inspection and Registration of Establishments; Official Names - Requires persons manufacturing, processing, repacking, labeling, or distributing a device subject to a standard which is in effect, or with respect to which there is in effect an approval of an application for scientific review, to maintain records and make reports to the Secretary on clinical experience and other data relating to the safety or effectiveness of such device, or possibility of adulteration or misbranding.

Title VII: General Provisions - Establishes an Advisory Council on Devices to advise the Secretary on policy matters relating to carrying out the provisions of the Act.

Prohibits States from establishing or maintaining standards or regulations for any device which is specifically subject to an official Federal standard or scientific review, unless State requirements are identical to the Federal requirements.

Permits the Secretary to disclose information relating to trade secrets to a contractor in furtherance of provisions of the Act, subject to the contractor's observance of such security precautions as are prescribed in the regulations.

Defines the term "device" to mean instruments, apparatus, implements, machines, contrivances, implants, in vitro reagents, or similar articles, including their components, parts and accessories which are: (1) recognized in the official U.S. Pharmascopela or National Formulary, or any supplement to them, or (2) intended for use in diagnosis, treatment, or prevention of disease in man or other animals, or (3) intended to affect any structure or any function of the body of man or other animals, and (4) which do not achieve any of their principal purposes through chemical action within or on the body of man or other animals and which are not dependent upon being metabolized for achievement of their principal purposes. Defines the term "prescription device".

Makes various technical amendments to the Federal Food, Drug, and Cosmetic Act to make existing law applicable to devices.