Regulatory Resources
MDCG guidance documents, EU regulations, standards, and compliance tools
All Categories
Annex XVI Products 3
Borderline and Classification 5
Class I Devices 1
Clinical Investigation and Evaluation 17
EU Regulation 2
EUDAMED 2
FDA Guidance 106
IVDR 2
MDCG Guidance 69
MDR 15
New Technologies 7
Notified Bodies 4
Other / Transition 5
Post-Market Surveillance and Vigilance 4
Standards 1
UDI 3
White Paper 15
175 Resources
Factors to Consider When Making Benefit-Risk Determinations for Medical Device IDEs
Final FDA guidance on ide. Published 2017 by CDRH/CBER.
Download PDFDesign Considerations and Premarket Submission Recommendations for Interoperable Medical Devices
Final FDA guidance on interoperability. Published 2017 by CDRH/CBER.
Download PDFEvaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies
Final FDA guidance on clinical evidence. Published 2017 by CDRH/CBER.
Download PDFUser Fees for 513(g) Requests for Information
Final FDA guidance on user fees. Published 2017 by CDRH/CBER.
Download PDFFDA and Industry Actions on 510(k) Submissions: Effect on FDA Review Clock and Goals
Final FDA guidance on 510(k). Published 2017 by CDRH/CBER.
Download PDFFDA and Industry Actions on PMA Submissions: Effect on FDA Review Clock and Goals
Final FDA guidance on pma. Published 2017 by CDRH/CBER.
Download PDFDeciding When to Submit a 510(k) for a Software Change to an Existing Device
Final FDA guidance on software & digital health. Published 2017 by CDRH/CBER.
Download PDFUnique Device Identification: Direct Marking of Devices
Final FDA guidance on udi. Published 2017 by CDRH/CBER.
Download PDFTechnical Considerations for Additive Manufactured Medical Devices
Final FDA guidance on manufacturing. Published 2017 by CDRH/CBER.
Download PDFMedical Device Accessories — Describing Accessories and Classification Pathways
Final FDA guidance on classification. Published 2017 by CDRH/CBER.
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