How to submit preclinical data to ODE

Elisa Harvey, Semih Oktay, Daniel Chwirut, Judy Danielson

Research output: Contribution to specialist publicationArticle

Abstract

Companies wanting to submit investigational device exemption (IDE) applications or marketing applications to FDA must give clear, concise documents that include a description of the preclinical evaluation of the device. Preclinical evaluation includes all nonclinical testing done to support an IDE or marketing application to FDA, while it may also include bench, animal, biocompatibility, and sterility testing. One of the most important pieces of information that FDA considers in determining whether testing provided is sufficient to support the application is the relevance of tests to the proposed intended use. Companies should also develop comprehensive risk analysis, and, if needed, check with FDA to ensure the analysis is sufficient. Detailed contact information for all test laboratories that have conducted any of a sponsor's testing should also be provided in the test reports to avoid response deficiencies from FDA.

Original languageEnglish (US)
Pages32-37
Number of pages6
Volume30
No7
Specialist publicationMedical Device and Diagnostic Industry
StatePublished - Jul 1 2008

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