REGULATORY OUTLOOK

1. Poor or uninformed choices of appropriate test models (bench and animal).
2. Insufficient proofreading of documents to be submitted.
3. Inadequate risk analysis.
4. Inadequately defined intended use and indications.
5. Poor study design.
6. Failure to properly identify standards, guidance documents, and precedents.
7. Lack of justification of test acceptance criteria.
8. Failure to submit raw data for all preclinical testing included in submission.
9. Vague descriptions of test methodology.
10. Inadequate presentation of test reports for FDA audience.