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Interactions as Seen by an Industry Representative among the FDA, the ADA, and Industry in Preparing a Restorative Material for Market
Author(s) -
Dougherty Emery W.
Publication year - 1992
Publication title -
journal of public health dentistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.64
H-Index - 63
eISSN - 1752-7325
pISSN - 0022-4006
DOI - 10.1111/j.1752-7325.1992.tb02307.x
Subject(s) - food and drug administration , business , marketing , medicine , accounting , family medicine , risk analysis (engineering)
The regulation of a restorative material in the international and the American markets is discussed. The 510(k) process of approval by the Food and Drug Administration allows marketing of safe, effective, and improved materials in the shortest time at the lowest cost. The American Dental Association contributes to developing consensus performance standards in the United States. Acceptance of International Standards Organization standards is discussed.