Exemptions granted and identified with "RWDxxxxxxx" in MAUDE, where RWD stands for real-world data, and xxxxxxx is replaced with a unique RWD exemption identifier, represent reports where the information submitted by the manufacturer was collected from certain real-world data sources, such as registries, electronic health records, or medical claims.The FDA seeks to include all reports received prior to the update but the inclusion of some reports may be delayed. MAUDE is updated monthly and the search page reflects the date of the most recent update.For example, "(b)(4)" may be found in place of the product's composition and "(b)(6)" may be found in place of a patient's age. The designations "(b)(4)" and "(b)(6)" refer to the exemptions in the FOIA. If a report contains personnel or medical files information, that text is replaced by "(b)(6)". If a report contains trade secret or confidential business information, that text is replaced by "(b)(4)".
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