ance with Sections 513 and 514, into one of the three following classes, and shall, to the extent practicable, assign priorities within classes: "(1) Those devices (a) for which insufficient information exists to (i) assure effectiveness, or (ii) assure that exposure to such devices will not cause unreasonable risk of illness or injury, and (b) for which standards or other means may not be appropriate to reduce or eliminate such risks of illness or injury and which therefore should be subject to premarket scientific review pursuant to Sec. 514. "(2) Those devices for which, in order to assure effectiveness or to reduce or eliminate unreasonable risk of illness or injury, it is appropriate to reasonable performance standards pursuant to Sec. 513, relating to safety and effectiveness of such devices and for which it is determined that no other more practicable means to reduce or eliminate such risk of illness or injury is available to the Secretary. "(3) Those devices which are safe and effective when used in conjunction with instructions for usage and warnings of limitation, which are adequate for the persons by whom the device is represented or intended for use, which present a minimum risk, and which should be exempt from requirements for scientific review or performance standards." W. Gerald Rainer, M.D., Association for the Advancement of Medical Instrumentation, and the American Heart Association. 5. Amendment to Sec. 511 (c) (1) of the Act as amended by Sec. 101 of the bill (p. 4, line 7): Amend Sec. 511 (c) (1) by deleting the entire paragraph, and inserting in lieu thereof the following: "(1) Those devices (a) for which inadequate evidence exists (i) to assure reasonable safety and effectiveness, or (ii) to insure that exposure to such devices will not cause unreasonable risk of illness or injury, (b) which are (i) life-sustaining (directly used for maintaining or supporting life itself) or (ii) life-threatening (failure during use poses a substantial direct risk or threat to the continuation of life itself), and (c) for which standards may not be appropriate, and which therefore should be subject to premarket scientific review pursuant to Sec. 514(a). In making the foregoing determinations, the panel shall consider the safety and effectiveness of the intrinsic characteristics of the device and shall not give weight to the collateral risks not directly related to the device itself (e.g. the effects of anesthesia during surgical implantation of a device)." and Amendment to Sec. 514 (a) as amended by Sec. 301 (b) of the bill (p. 20, line 15): Amend Sec. 514 (a) by deleting the word "To" at the beginning of line 5, p. 21, and inserting in lieu thereof the following: "In addition to the provisions of Sec. 511(a), to . . ." Robert T. Rylee, II, President, Orthopaedic Surgical Manufacturers Association, and President, Wright Manufacturing Company. 6. Recommendation for Sec. 511 (c) (1) of the Act as amended by Sec. 101 of the bill (p. 4, line 7), concerning criteria for requiring premarket scientific review: Charles C. Edwards, M.D., Assistant Secretary for Health, Department of Health, Education, and Welfare, suggests that the criteria for requiring premarket scientific review be changed to use the language of H.R. 6073, limiting these reviews to "life-threatening" devices. William R. Barclay, M.D., Assistant Executive Vice-President, American Medical Association. 7. Amendment to Sec. 511 (c) (1) as amended by Sec. 101 of the bill (p. 4, line 7): Amend to insert at the end of Sec. 511 (c) (1), the following: "Such review, either initial or continuing, shall be required if the panels determine that such device is: life-sustaining or life-supporting or potentially hazardous to life or good health.” Senator Gaylord Nelson, Wisconsin. 8. Amendment to Sec. 511 (c) (1) of the Act as amended by Sec. 101 of the bill (p. 4, line 7): Amend Sec. 511 (c) (1) to insert the words "serious and Stuart N. Davidson, Corporate Director, Government Affairs, 9. Recommendation for Sec. 511 (c) (1) of the Act as amended by the bill (p. 4, line 7): Robert A. Teckemeyer, Director, Government Relations, American Physical Therapy Association, suggests that devices which emit energy, either ionizing or non-ionizing, be required to undergo premarket scientific review. 10. Amendment to Sec. 511 (c) (1) of the Act, as amended by Sec. 101 of the bill (p. 4, line 7): Amend Sec. 511 (c) (1) to insert the word "reasonable" before Stuart N. Davidson, Corporate Director, Government Affairs, 11. Amendment to Sec. 511 (c) (1) of the Act as amended by Sec. 101 of the bill (p. 4, line 7): Amend Sec. 511 (c) (1) to strike the entire paragraph, and substitute the following new language: "Those devices which (a) are implanted within the body, or contact mucous membranes for prolonged periods of time; (b) are life-supporting; (c) are life-sustaining; (d) emit ionizing radiation or other forms of energy; or (e) are potential hazards to good health should be subject to premarket scientific review pursuant to Sec. 514(a)." Sidney M. Wolfe, Health Research Group. 12. Recommendation for Sec. 511 (c) (1) of the Act as amended by Sec. 101 of the bill (p. 4, line 7): W. Gerald Rainer, M.D., Association for the Advancement of Medical Instrumentation, and the American Heart Associa-tion, suggests that Sec. 511 (c) (1) be amended to include the provision of HR 6073 (p. 16, line 15), that scientific review be required only if "... no more practicable means to reduce this hazard [presented by the device] are available to the Secretary." 13. Amendment to Sec. 511 (c) (1) of the Act as amended by Sec. 101 of the bill (p. 4, line 7): Amend Sec. 511 (c) (1) to insert a provision that a manufac- W. Gerald Rainer, M.D., Association for the Advancement of 14. Amendments to Sec. 511 of the Act as amended by Sec. 101 of the bill: Amend Sec. 511 as follows: Page 2 line 17-replace the words "may utilize" with the words "shall consider". Page 2 line 18-delete the words "and findings". Page 2 line 21-after the word "members" insert the following: "shall be qualified by training and experience to evaluate the safety and effectiveness of devices in the category or class of devices to be referred to such a panel and". Page 4 line 7-replace the phrase "inadequate evidence” with the phrase "insufficient information". Page 4 line 8-strike the phrase "safety and". Page 4 line 9-replace the word "insure" with the word "assure". Page 4 lines 10-13-delete all after the word "and" and replace with: "(b) and for which scientific review may assure effectiveness or may reduce or eliminate such unreasonable risk and no more practicable means to assure effectiveness or to reduce or eliminate the unreasonable risk are appropriate”. Page 4 line 14-after the word "to" insert the phrase "assure effectiveness or". · Page 4 line 16-insert the word "performance" before the word "standards". Page 4 line 18-add the phrase "and no more practicable means to assure effectiveness or to reduce or eliminate the unreasonable risk are appropriate". Page 4 lines 19-24-delete and replace with the following: "(3) those devices which are safe and effective when used in conjunction with instructions for usage and warnings of limitation, which are adequate for the persons by whom the device is represented or intended for use, which present only a reasonable risk and which therefore should be exempt from requirements for scientific review of performance standards". Page 5 lines 12-15-delete and replace with the following: "(e) the Secretary, with the advice of the appropriate panel and after making a specific finding and publishing such finding in the Federal Register and providing interested persons an opportunity for comment thereon may by regulation change the preliminary classification of a device or group of devices from one category to another". Page 5 after line 15-insert the following: "(f) The preliminary classification of a device shall constitute public notice that, as expeditiously as is feasible, the Secretary will issue a final classification in the form of a determination of a need for a performance standard pursuant to section 513 or a determination of the need for scientific review pursuant to section 514. The preliminary classification shall not relieve the Secretary of any obligation to provide notice as required by sections 513 and 514. Any interested person will have an opportunity, pending such final classification, to undertake studies and other work appropriate to develop a performance standard or to demonstrate the safety and effectiveness of a device". Page 5-after the language insert as a result of (13) above, insert the following: "(g) After the promulgation of final regulations referred to under subsection (f) of this section, and commensurate with the effective date of section 501 (f), a manufacturer of a medical device which differs substantially from those classified in final regulations shall file an application for the classification of the device and must receive from the Secretary notification of the classification of such device. The Secretary shall act on the application within sixty days unless the Secretary and the manufacturer agree to an additional period of time. The Secretary 7 shall classify the devices in accordance with the criteria and procedures listed in 511, 513, and 514 including the requirement for consultation with the appropriate panel or panels. The appeal provisions of sections 513 and 514 shall apply". Rodney R. Munsey for various trade associations. 15. Amendment to several sections of the Act as amended by the bill: Amend as follows: Insert the word "performance" before the word "standard" in the following locations throughout the bill: Page 5-lines 16 and 21; page 6-lines 7, 8, 12, 20, and 25, page 7-lines 7, 8, and 16; page 8-lines 3, 15, 20, and 22; page 9-lines 7, 10, 11, 15 and 18; page 10-lines 13 18, 23, and 25; page 11-lines 2, 5, 9, 11, 18, and 24; page 12-lines 1, 6 (twice), 8, 13, 14, 17, 20 (twice), and 22; page 13-lines 4, 5, 7, and 9; page 14-lines 13, 15, and 18; page 15-lines 7 and 13; page 18-lines 3, 8, 12, 20, and 25; page 19-lines 20 and 22; page 20-lines 1 and 4; page 23-lines 22 and 25; page 26-line 12; page 30-line 11; page 46— line 19; page 49-lines 4 and 9; page 51-line 13; page 55-line 24; page 57-line 6; page 61-line 18; and page 63-line 4. Rodney R. Munsey for various trade associations. 16. Amendment to Sec. 513(a) (1) of the Act as amended by Sec. 201 of the bill (p. 5, line 23): Amend Sec. 513(a) (1) to delete the following beginning on p. 6, line 13 of the bill: 66 (incuding, where reasonably necessary to assure the accuracy and reliability of results, individual lot test- William R. Barclay, Assistant Executive Vice-President, 17. Recommendation for Sec. 513 (a) (1) of the Act as amended by Sec. 201 of the bill (p. 5, line 23): Charles M. Evans, President-elect, Medical-Surgical Manufacturers Association, and President, Welch Allyn, Inc., suggests that standards be limited to performance criteria alone. 18. Amendment to Sec. 513 (e) (1) of the Act as amended by Sec. 201 of the bill (p. 9, line 13): Amend Sec. 513 (e) (1) to strike lines 13-21, p. 9 of the bill and substitute the following new language: "(e) (1) The Secretary shall require, by regulation, that, in making an offer, each offeror and appropriate individual employees, officers, consultants, and directors of each offeror company disclose the following information: 28-427-74-2 |