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.

FDA Guidance

Official FDA guidance documents for medical devices and radiation-emitting products

106 resources

106 resources

Recommendations for CLIA Waiver Applications for In Vitro Diagnostic Devices

FDA Guidance 2020-02-01 FDA Guidance

Final FDA guidance on ivd & diagnostics. Published 2020 by CDRH/CBER.

FDA Guidance

Recommendations for CLIA Waiver Applications for In Vitro Diagnostic Devices

Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions

30-Day Notices, 135-Day PMA Supplements and 75-Day HDE Supplements for Manufacturing Changes

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

Developing and Labeling In Vitro Companion Diagnostic Devices for Oncology Therapeutic Products

Nonbinding Feedback After Certain FDA Inspections of Device Establishments

Providing Regulatory Submissions for Medical Devices in Electronic Format — Section 745A(b)

Review and Update of Device Establishment Inspection Processes and Standards

Recognition and Withdrawal of Voluntary Consensus Standards

Multiple Function Device Products: Policy and Considerations

Safer Technologies Program for Medical Devices (STeP)

Acceptance Review for De Novo Classification Requests

Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)

User Fees and Refunds for De Novo Classification Requests

FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals

De Novo Classification Process (Evaluation of Automatic Class III Designation)

Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments

Study Data Technical Conformance Guide

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices

Electromagnetic Compatibility (EMC) of Medical Devices

Content of Premarket Submissions for Device Software Functions

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

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