This article was originally published in The Gray Sheet
FDA has 60 days from the publication of a call for premarket approval applications for a pre-1976 device to approve or deny reclassification petitions. "The Gray Sheet" (July 21, p. 14) incorrectly reported that FDA has 210 days to respond to petitions after a call for PMAs. FDA regs provide the agency with 210 days to respond to reclassification petitions for post-1976 Class III devices.
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