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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

FDAMA six-year rule: Provision allowing information from a PMA submission, six years after approval, to be applied in support of other PMA decisions "conceivably...could be used in biocompatibility" tests, CDRH Director David Feigal notes at a Jan. 31 National Forum on Biomedical Imaging in Oncology meeting. Safety and effectiveness data from six-year-old PMAs may be "sort of like an automatic cross reference," Feigal said. The option will be available in two years...
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