Guidances for third-party eligible devices
This article was originally published in The Gray Sheet
FDA releases guidance documents on its website (www.fda.gov/cdrh) for seven in vitro diagnostic devices and a surgical lamp. The eight products were included in a list of 26 additional devices for which the agency plans to develop guidance prior to the Nov. 21 start-up of its "Accredited Persons" third-party review program ("The Gray Sheet" July 13, p. 6)
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