CDRHNew: FR Doc 2010-19339 and Draft Guidance for Industry for Premarket Notifications for Lamotrigine and Zonisamide

The following new items were added to the CDRH web pages on August 5, 2010.

1. Federal Register: Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, and Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations; Availability; Request for Comments -
open here to see the full-text:
FR Doc 2010-19339


2. Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays
Guidance Documents (Medical Devices and Radiation-Emitting Products) > Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays