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Page 45

22. Author's telephone conversations with Frank Brutomesso,

UL Standards Department.

23. "Method of Development, Revision and Implementation of

UL Standards for Safety" (Northbrook, Ill.: Underwriters

Laboratories, Inc.), pp. 10-11.

24. Underwriters Laboratories, 1994 Annual Report, p. 10.

25. Author's telephone conversation with Roy Resnick, Occu-

pational Safety and Health Administration, December 6, 1996.

26. Author's telephone conversations with Frank Brutomesso,

UL Standards Department.

27. General Accounting Office, "Medical Device Regulation:

Too Early to Assess European System's Value as Model for

FDA," March 1996, p. 3.

28. For supporting examples, see Higgs.

29. Higgs, pp. 14-15 and endnotes.

30. Peter Barton Hutt quoted in ibid., p. 9 and endnotes.

31. General Accounting Office, "Medical Devices: FDA Review

Time," October 1995.

32. Ibid., pp. 5-16.

33. Ibid., p. 73.

34. Ibid., p. 15.

35. David Masci with Steve Langdon, "Bill to Overhaul FDA

Process Gets Nod from Panel," Congressional Quarterly Week-

ly, March 30, 1996, p. 887.

36. Robert M. Goldberg, "Why Kessler Must Go," Wall Street

Journal, April 4, 1996.

37. Steve Langdon, "FDA Drug Approval Process May Undergo

Surgery," Congressional Quarterly Weekly, January 27, 1996,

p. 223.

38. General Accounting Office, "Medical Devices," p. 75.

39. Higgs, p. 14.