Regulatory Resources
MDCG guidance documents, EU regulations, standards, and compliance tools
175 Resources
Providing Information about Pediatric Uses of Medical Devices
Final FDA guidance on pediatric devices. Published 2014 by CDRH/CBER.
Download PDFIn Vitro Companion Diagnostic Devices
Final FDA guidance on ivd & diagnostics. Published 2014 by CDRH/CBER.
Download PDFFDA Decisions for Investigational Device Exemption Clinical Investigations
Final FDA guidance on ide. Published 2014 by CDRH/CBER.
Download PDFDesign Considerations for Devices Intended for Home Use
Final FDA guidance on design controls. Published 2014 by CDRH/CBER.
Download PDFReprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Final FDA guidance on labeling. Published 2015 by CDRH/CBER.
Download PDFBalancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
Final FDA guidance on pma. Published 2015 by CDRH/CBER.
Download PDFLeveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
Final FDA guidance on pediatric devices. Published 2016 by CDRH/CBER.
Download PDFAdaptive Designs for Medical Device Clinical Studies
Final FDA guidance on clinical evidence. Published 2016 by CDRH/CBER.
Download PDFPatient Preference Information — Voluntary Submission and Review in PMA/HDE/De Novo
Final FDA guidance on patient engagement. Published 2016 by CDRH/CBER.
Download PDFPostmarket Management of Cybersecurity in Medical Devices
Final FDA guidance on cybersecurity. Published 2016 by CDRH/CBER.
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