Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays: Guidance for Industry and Food and Drug Administration Staff

Issue Date: February 9, 2016
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k)
Status: Final

Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays: Guidance for Industry and Food and Drug Administration Staff

This guidance document contains recommendations to manufacturers and FDA reviewers concerning information to include in premarket notifications for assays for the anti-seizure drugs, lamotrigine and zonisamide. These assays are intended to quantitatively measure concentrations of the respective drugs in serum or plasma as an aid in the management of patients treated with lamotrigine or zonisamide. The recommendations are based on current review practices as well as information regarding zonisamide and lamotrigine that were submitted to FDA by the Therapeutic Drug Monitoring Roundtable. Some of the general concepts in this guidance may also be helpful in preparing 510(k) submissions for other therapeutic drug assays previously cleared by FDA, and classified within 21 CFR 862 subpart D.

Download the Guidance Document