In vitro fertilization devices
This article was originally published in The Gray Sheet
Executive SummaryMakers of IVF devices already in commercial distribution will be allowed to continue marketing the products provided that they have submitted a 510(k) for each device marketed in the U.S. within 60 days, FDA says in a letter posted on its website Feb. 19. Additionally, makers of the devices, which were reclassified into either Class II or Class I in October ("The Gray Sheet" Sept. 14, 1998, p. 16), must register their products and list their establishments with the agency. Adherence to the quality system regulation and "other pertinent FDA regulations," such as medical device reporting, labeling and corrections and removals, also is required. Firms in compliance with the stipulations and the reclassification document may continue marketing their devices until FDA determines that the products are substantially equivalent. Devices found not substantially equivalent will require a premarket application approval to be approved before marketing may resume, the agency says
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