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

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.

FDA Guidance

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

User Fees for 513(g) Requests for Information

Deciding When to Submit a 510(k) for a Software Change to an Existing Device

Technical Considerations for Additive Manufactured Medical Devices

Unique Device Identification: Direct Marking of Devices

Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based IVDs

Acceptance of Clinical Data to Support Medical Device Applications and Submissions: FAQ

FDA Categorization of IDE Devices to Assist CMS with Coverage Decisions

Medical Device Accessories — Describing Accessories and Classification Pathways

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

Use of Electronic Health Record Data in Clinical Investigations

Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests

User Fees and Refunds for Premarket Approval Applications and Device BLAs

Manufacturing Site Change Supplements: Content and Submission

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in 510(k) Submissions

Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo

Unique Device Identification: Convenience Kits

The Least Burdensome Provisions: Concept and Principles

Humanitarian Device Exemption (HDE) Program

Refuse to Accept Policy for 510(k)s

The Abbreviated 510(k) Program

The Special 510(k) Program

Annual Reports for Approved Premarket Approval Applications (PMA)

Safety and Performance Based Pathway

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