The regulatory process for dental devices: a researcher's view.
Comments from the three previous speakers ranged from moderate satisfaction to strong dissatisfaction with the regulatory process. Three different types of research are identified that seem to predict the ease of compliance with the 510(k) process. No one expressed satisfaction with the PMA application. It seems that current evaluation procedures inhibit the developing and marketing of new devices, but foster only enhancements to existing devices. The development of new evaluation methods is advocated to provide fast, inexpensive, but rigorous assessment of the clinical safety and treatment value of new devices.
de Rijk
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Division of Biomaterials, University of Texas Health Sciences Center, School of Dentistry, San Antonio 78249.
D000571:American Dental Association; D003748:Dental Equipment / Q000592:standards*; D003762:Dental Instruments / Q000592:standards*; D003764:Dental Materials / Q000592:standards; D012106:Research; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
D003764:Dental Materials