Use of Existing Bibliography Sample Clauses

Use of Existing Bibliography. Copies are required of all literature studies, or existing bibliography, that the product owner is using to support safety and effectiveness. These will be a subset of the bibliography of references. General bibliographic references should be device-specific as supplied in chronological order. Care should be taken to ensure that the references are timely and relevant to the current application. Clinical evidence of effectiveness may comprise device-related investigations conducted domestically or other countries. It may be derived from relevant publications in a peer-reviewed scientific literature. The documented evidence submitted should include the objectives, methodology and results presented in context, clearly and meaningfully. The conclusions on the outcome of the clinical studies should be preceded by a discussion in context with the published literature.
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Related to Use of Existing Bibliography

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