FDA Releases Anticipated Draft Laboratory-Developed Tests Guidance - McDermott+Consulting

FDA Releases Anticipated Draft Laboratory-Developed Tests Guidance

As noted in a previous +Insight, the Food and Drug Administration (FDA) has released its draft guidance on laboratory-developed tests (LDTs) under its authority.  Comments on the draft guidance are due February 2, 2015.

To view the draft guidance, please click here.

To view the Federal Register Notice, please click here.