COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE

HARLEY O. STAGGERS, West Virginia, Chairman

TORBERTH. MACDONALD, Massachusetts

JOHN JARMAN, Oklahoma

SUGGESTED AMENDMENTS TO H.R. 9984

1. Amendment to Sec. 511 of the Act as amended by Sec. 101 of the bill (p. 2, line 2):

Amend Sec. 511 by deleting subsection (a) and substituting therefor the following:

"Sec. 511. (a) Within sixty days after funds are first appropriated for the implementation of this section, the Secretary shall appoint and organize classification panels of experts with there being one such panel for each medical specialty recognized as a specialty by the medical community plus such other panels as the Secretary shall deem appropriate or necessary to consider devices which are not peculiar to a particular medical specialty. The composition of each such panel shall be equally divided among representatives of: (1) the subject medical interest, e.g. licensed active practitioners of that medical specialty or group; (2) the subject industry or individual manufacturers of the device or class or types of devices being considered; (3) consumer interests, whether direct users or academic or research groups; and (4) the Federal Government. No appointee may serve in a dual representative capacity and no Federal Government employee may serve except as a representative of the Federal Government. Each such appointee shall be qualified by scientific training and/or experience to review and classify devices into appropriate categories based on the safety and effectiveness of such devices. Each panel shall review all devices within its respective scientific field for purposes of appropriate classification and shall submit within one year of its appointment a first report of its findings and conclusions. For purposes of this classification, all devices then being marketed not specifically classified by the panel as being in class (1) of subsection (c) of this section, requiring premarket scientific review or class (2) requiring standards, shall be deemed to be in class (3), exempt. In order to classify a device within said class (1) requiring premarket scientific review, the panel must have a consensus opinion on each such device of at least two-thirds of the members of this panel; to classify a device within said class (2) requiring standards, the panel must have a consensus on such device of at least a majority of members of the panel. To the maximum extent possible, each such panel shall provide an opportunity for the manufacturer and any other interested person to submit data and views on the classification of the device or type or class of device. Be

(1)

4

fore a device may be classified in class (1) requiring premarket scientific review, each manufacturer registered with the Secretary pursuant to section 603 (a) hereof as a manufacturer of such device or type or class of device and each professional group that is representative of the user of such device or type or class of device shall be given at least ten days advance notice by U.S. Mail of the panel meeting at which such device will be considered, so that such persons may appear and present their views on such classification. The Secretary may utilize any such panels which may have been formed for the purpose of such classification prior to enactment of this section, provided that any classification into class (1) requiring premarket scientific review must have been made in accordance with the foregoing provisions or else be reconsidered in compliance herewith. Such panels shall also serve as scientific review panels under Section 514 hereof."

Robert T. Rylee, II, President, Orthopedic Surgical Manufacturers Association, and President, Wright Manufacturing Company.

2. Recommendation for Sec. 511 (a) of the Act as amended by Sec. 101 of the bill (p. 2, line 2):

That the classification panels of this section be made perma-
nent, to permit classification of new or improved devices.

W. Gerald Rainer, M.D., Association for the Advancement of
Medical Instrumentation, and the American Heart Association.
Also suggested by Dwight Emary Harken, M.D., American
College of Cardiology.

3. Amendment to Sec. 511(b) of the Act as amended by Sec. 101 of the bill (p. 2, line 21):

Amend Sec. 511(b) to:

(1) Insert the word "manufacturing" before "trade" in line 24, page 2, and

(2) Add the following to the end of the sentence ending on page 3, line 5:

".. and shall include a balanced representation of
members selected from scientific manufacturing, trade,
and consumer organizations.”

Stuart N. Davidson, Corporate Director, Government Affairs,
Beckman Instruments, Inc.

4. Amendment to Sec. 511 (c) of the Act as amended by Sec. 101 of the the bill (p. 3, line 25):

Amend to strike Sec. 511 (c) (p. 3, line 25 through p. 4, line 24) and insert in lieu thereof the following:

"(c) Panels appointed pursuant to subsection (a) shall submit (in the final report of the panel or such interim reports as may be appropriate) recommendations for the classification of devices, for the purposes of and in accord