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

106 resources

Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act

FDA Guidance 2022-11-01 FDA Guidance

Final FDA guidance on classification. Published 2022 by CDRH/CBER.

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Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions

FDA Guidance 2022-10-01 FDA Guidance

Final FDA guidance on submission process. Published 2022 by CDRH/CBER.

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Policy for Device Software Functions and Mobile Medical Applications

FDA Guidance 2022-09-01 FDA Guidance

Final FDA guidance on software & digital health. Published 2022 by CDRH/CBER.

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Recommendations for the Use of Clinical Data in Premarket Notification 510(k) Submissions

FDA Guidance 2023-09-01 FDA Guidance

Draft FDA guidance on clinical evidence. Published 2023 by CDRH/CBER.

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Evidentiary Expectations for 510(k) Implant Devices

FDA Guidance 2023-09-01 FDA Guidance

Draft FDA guidance on 510(k). Published 2023 by CDRH/CBER.

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Best Practices for Selecting a Predicate Device to Support a 510(k) Submission

FDA Guidance 2023-09-01 FDA Guidance

Draft FDA guidance on 510(k). Published 2023 by CDRH/CBER.

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Breakthrough Devices Program

FDA Guidance 2023-09-01 FDA Guidance

Final FDA guidance on breakthrough devices. Published 2023 by CDRH/CBER.

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Use of International Standard ISO 10993-1: Biological Evaluation of Medical Devices

FDA Guidance 2023-09-01 FDA Guidance

Final FDA guidance on biocompatibility. Published 2023 by CDRH/CBER.

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Submission and Review of Sterility Information in Premarket Notification 510(k) Submissions for Devices Labeled as Sterile

FDA Guidance 2024-01-01 FDA Guidance

Final FDA guidance on 510(k). Published 2024 by CDRH/CBER.

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Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices

FDA Guidance 2023-11-01 FDA Guidance

Final FDA guidance on export & international. Published 2023 by CDRH/CBER.

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Regulatory Resources

Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act

Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions

Policy for Device Software Functions and Mobile Medical Applications

Recommendations for the Use of Clinical Data in Premarket Notification 510(k) Submissions

Evidentiary Expectations for 510(k) Implant Devices

Best Practices for Selecting a Predicate Device to Support a 510(k) Submission

Breakthrough Devices Program

Use of International Standard ISO 10993-1: Biological Evaluation of Medical Devices

Submission and Review of Sterility Information in Premarket Notification 510(k) Submissions for Devices Labeled as Sterile

Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices

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