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

摘要

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.