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Guidance Issuing OfficeCenter for Devices and Radiological Health
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2010-D-0395.