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Regulations of Assisted Reproduction Devices in the United States, Premarket Notification [510(k)]

ABSTRACT In the United States, assisted reproduction devices are categorized as “medical devices” and regulated by FDA. Most of assisted reproduction devices are classified in Class II based on level of control necessary to assure the safety and effectiveness as well as on risk to patient and/or user. Manufactures must submit a 510(k) to FDA before introducing a device to the U. S. market. Assisted Reproduction devices should be manufactured in accordance with Good Manufacturing Practice (GMP) and manufactures must demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. The status of regulations and the contents required to applicants in the U. S. are reported.