Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period

Streszczenie

The Food and Drug Administration (FDA) is extending to October 12, 2011, the comment period for the notice that appeared in the Federal Register of July 14, 2011 (76 FR 41506). In the notice, FDA requested comments on a draft guidance document entitled "In Vitro Companion Diagnostic Devices." The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.