Report to Congress; Report on the Food and Drug Administration's Policy To Be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices; Notice to Public of Web Site Location of Report to Congress

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The Food and Drug Administration (FDA or the Agency) is announcing the Web site location where the Agency has posted the report entitled "Report to Congress; Report on FDA's Policy to be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices." In addition, FDA has established a docket where stakeholders may provide comments.