FULL COMMITTEE ACTION

Friday, September 26, 1997

Prepared by the Commerce Committee Democratic Staff
H.R. 1710:MEDICAL DEVICE REGULATORY MODERNIZATION ACT OF 1997 , was ORDERED FAVORABLY REPORTED, AMENDED, by a voice vote.

A Committee Print of H.R. 1710, showing the text of the bill as reported by the Subcommitee on Health and Environment on September 17, 1997, was made in order as original text for purposes of amendment.

The following amendments were offered:

An amendment in the nature of a substitute by Mr. Barton, #1, was ADOPTED, as amended, by a voice vote;

An amendment to the Barton amendment in the nature of a substitute by Mr. Waxman, #1A, re: surveillance approval, was WITHDRAWN with no objection;

An amendment to the Barton amendment in the nature of a substitute by Mr. Barton, #1B, re: labeling and advertising regarding compliance with statutory requirements, was ADOPTED by a voice vote;

An amendment to the Barton amendment in the nature of a substitute by Mr. Barton and Ms. Eshoo, #1C, re: safeguards in the scope of 510(k) application review, was ADOPTED by a voice vote;

An amendment to the Barton amendment in the nature of a substitute by Ms. Furse and Mr. Barton, #1D, re: noninvasive blood glucose meter, was ADOPTED by a voice vote;

An amendment to the Barton amendment in the nature of a substitute by Mr. Klug, #1E, re: maintaining the classification of Class I devices, was WITHDRAWN with no objection;

An amendment to the Barton amendment in the nature of a substitute by Mr. Markey, #1F, re: to strike language on device tracking and postmarket surveillance, was WITHDRAWN with no objection;

An amendment to the Barton amendment in the nature of a substitute by Mr. Waxman, #1G, re: definition of the role of the Food and Drug Administration in the regulation of the practice of medicine, was WITHDRAWN with no objection;

An amendment to the Barton amendment in the nature of a substitute by Mr. Waxman, #1H, re: devices eligible for accredited person review, was WITHDRAWN with no objection;

The Committee adjourned subject to the call of the Chair

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