CDRHNew
Date: October 1, 2014
The following new items were added to the CDRH web pages on September 30, 2014. Previous CDRH New Items can be found on the CDRHNew Page.
- Discussion Paper: Brain-Computer Interface (BCI) Devices for Patients with Paralysis and Amputation
- Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) (PDF - 565KB)
- Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (PDF - 312KB)
- FDA Consumer Update: 3D Technologies Poised to Change How Doctors Diagnose Cancers
- National Medical Device Curriculum Case Study #5
- Updates Reflecting FY 2015 Medical Device User Fee Amendments (MDUFA III) Fees
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