What is an MDCG guidance document?

MDCG (Medical Device Coordination Group) guidance documents are non-binding technical guidance published by the European Commission to assist manufacturers, Notified Bodies, and competent authorities in implementing EU MDR 2017/745 and EU IVDR 2017/746. They cover clinical evaluation, post-market surveillance, UDI, EUDAMED, and other compliance topics.

What FDA guidance documents are required for a 510(k) submission?

FDA 510(k) submissions must follow applicable FDA guidance documents including the general 510(k) Guidance, device-specific guidances, and quality system regulation (21 CFR Part 820). Key documents include guidance on substantial equivalence determinations, cybersecurity pre-market requirements, and device-type-specific performance standards.

What is a Team NB document?

Team NB (Team of Notified Bodies) publishes position papers, recommendations, and guidance documents developed collaboratively by European Notified Bodies designated under EU MDR and IVDR. These documents clarify application of regulatory requirements and support harmonised conformity assessment practices across Notified Bodies.

What clinical guidelines are available on Medical Device Navigator?

Medical Device Navigator provides access to 700+ clinical guidelines and recommendations from major European and American medical societies including ESC, ESMO, EULAR, AHA/ACC, ASCO, ADA, NICE, and many more. Guidelines are organized by specialty and geographic scope (European vs American) to help medical device professionals understand clinical practice standards relevant to their devices.

Regulatory Resources

Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools

1,129 resources

Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices

FDA Guidance 2016-06-01 FDA Guidance

Final FDA guidance on pediatric devices. Published 2016 by CDRH/CBER.

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Adaptive Designs for Medical Device Clinical Studies

FDA Guidance 2016-07-01 FDA Guidance

Final FDA guidance on clinical evidence. Published 2016 by CDRH/CBER.

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Patient Preference Information — Voluntary Submission and Review in PMA/HDE/De Novo

FDA Guidance 2016-08-01 FDA Guidance

Final FDA guidance on patient engagement. Published 2016 by CDRH/CBER.

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Postmarket Management of Cybersecurity in Medical Devices

FDA Guidance 2016-12-01 FDA Guidance

Final FDA guidance on cybersecurity. Published 2016 by CDRH/CBER.

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Factors to Consider When Making Benefit-Risk Determinations for Medical Device IDEs

FDA Guidance 2017-01-01 FDA Guidance

Final FDA guidance on ide. Published 2017 by CDRH/CBER.

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Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices

FDA Guidance 2017-09-01 FDA Guidance

Final FDA guidance on interoperability. Published 2017 by CDRH/CBER.

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Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies

FDA Guidance 2017-09-01 FDA Guidance

Final FDA guidance on clinical evidence. Published 2017 by CDRH/CBER.

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User Fees for 513(g) Requests for Information

FDA Guidance 2017-10-01 FDA Guidance

Final FDA guidance on user fees. Published 2017 by CDRH/CBER.

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FDA and Industry Actions on 510(k) Submissions: Effect on FDA Review Clock and Goals

FDA Guidance 2017-10-01 FDA Guidance

Final FDA guidance on 510(k). Published 2017 by CDRH/CBER.

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FDA and Industry Actions on PMA Submissions: Effect on FDA Review Clock and Goals

FDA Guidance 2017-10-01 FDA Guidance

Final FDA guidance on pma. Published 2017 by CDRH/CBER.

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Regulatory Resources

Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices

Adaptive Designs for Medical Device Clinical Studies

Patient Preference Information — Voluntary Submission and Review in PMA/HDE/De Novo

Postmarket Management of Cybersecurity in Medical Devices

Factors to Consider When Making Benefit-Risk Determinations for Medical Device IDEs

Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices

Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies

User Fees for 513(g) Requests for Information

FDA and Industry Actions on 510(k) Submissions: Effect on FDA Review Clock and Goals

FDA and Industry Actions on PMA Submissions: Effect on FDA Review Clock and Goals

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