Electronic copies requested for CDRH submissions

09/30/2008 | FDAnews

The FDA's Center for Devices and Radiological Health said medical-device manufacturers should add an electronic copy with the paper copies of their premarket submissions, such as 510(k), IDE and PMA. The electronic copy should be in the PDF format and stored on a CD or DVD. Files containing clinical data may be in SAS, XPORT, XML, SGML and Molfile formats.

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