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This library consists of a wide range of software related documents and focused excerpts of documents. A short abstract is usually provided for each document to summarize its purpose and use. Some documents are confidential or part of our paid subscription service - these documents have a "$" as part of their title. If you select one of these documents you will be prompted to enter your login if you have not already done so. 

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Please note that  FDA interpretation and enforcement practices sometimes vary from district to district and change continually. These changes often precede formalization in guidances and regulations.