FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive FDA – Guidance – How to Prepare a Pre-Request for Designation (Pre-RFD) | FDA New guidance has been issued regarding seeking designation of devices: How to Prepare a Pre-Request for Designation (Pre-RFD) | FDABen KempNovember 13, 2025