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Page 46

40. For a synopsis, see Higgs, pp. 24-35.

41. For a discussion of the inconsistent standards to which

Congress holds the FDA see Higgs.  See also "Industry Sways

Dingell to Its Side," Clinica, September 9, 1992; and U.S.

House of Representatives, Committee on Energy and Commerce,

Subcommittee on Oversight and Investigations, Less Than the

Sum of Its Parts: Reforms Needed in the Organization, Man-

agement, and Resources of the Food and Drug Administration's

Center for Devices and Radiological Health, 103d Cong., 1st

sess., Committee Print 103-N, May 1993.

42. American Electronics Association News Release, Washing-

ton, June 23, 1994.

43. Much of the following information is derived from au-

thor's conversations with Al Bracey, Division for Small

Manufacturer's Assistance, Center for Devices and Radiologi-

cal Health (CDRH), Food and Drug Administration.  All refer-

ences to Bracey result from the author''s telephone conver-

sation with him on September 18, 1996. Information not aris-

ing from this conversation is available on CDRH Web sites

concerning the pilot program, at www.fda.gov/cdrh/

3rdprty.html and www.fda.gov/cdrh/ohipfed.html.

44. See the Class II Devices link, at www.fda.gov

/cdrh/3rdprty.html.

45. Author's conversation with Al Bracey.

46. See the November 15, 1996, update at www.fda.gov/cdrh/

update.html, p.3.

47. Ibid., p. 1.

48. Committee on Labor and Human Resources, U.S. Senate,

Report 105-43 (Washington: U.S. Government Printing Office,

1997), p. 22.

49. "Information on Medical devices: Third Party Review of

Selected Pre-Market Notifications; Pilot Program," www.

fda.gov/cdrh/ohipfed.html, September 17, 1996.

50. Ibid.

51. Ibid.

52. Ibid.