Fise T F, Smith D L
J Am Dent Assoc. 1979 Nov;99(5):799-802. doi: 10.14219/jada.archive.1979.0401.
FDA authority over medical devices is a fact of life, certain to have an effect on the dental trade industry. Trends toward acquisitions and mergers of companies within the dental trade industry and the employment of additional personnel, in response to the regulations, have already become apparent. While some improvement in the quality of dental products can be anticipated, it is also expected that the regulations will result in fewer sources of dental products, higher costs for products fewer new products, and a reluctance to accept goods for return or repair. Whether the net impact of the Medical Device Amendments upon the industry will be positive or negative, remains to be seen.
美国食品药品监督管理局（FDA）对医疗器械的监管是不争的事实，必然会对牙科贸易行业产生影响。牙科贸易行业内企业的收购与合并趋势，以及为响应相关法规而增聘人员的情况已日益明显。虽然预计牙科产品质量会有所提高，但也预料到这些法规将导致牙科产品供应渠道减少、产品成本上升、新产品数量减少，以及不愿接受产品退货或维修。医疗器械修正案对该行业的总体影响是积极还是消极，仍有待观察。
