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

Description

Thisguidance documentcontains 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.

Scope & Applicability

Regulatory Context

• 21CFR809.10§ 809.10 Labeling for in vitro diagnostic products.

  (a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that “a Read full regulation →

• 21CFR862.3350§ 862.3350 Diphenylhydantoin test system.

  (a) Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin tRead full regulation →

• 21CFR610.40§ 610.40 Test requirements.

  (a) Human blood and blood components. Except as specified in paragraphs (c) and (d) of this section, you, an establishment that collects blood and blood components for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medicalRead full regulation →

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