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

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.

FDA Guidance

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

Electronic Submission Template for Medical Device 510(k) Submissions

FDA and Industry Procedures for Section 513(g) Requests for Information

Predetermined Change Control Plans for Medical Devices

Remanufacturing of Medical Devices

Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

Electronic Submission Template for Medical Device De Novo Requests

Biocompatibility Testing of Medical Devices — ASCA Program

The Accreditation Scheme for Conformity Assessment (ASCA) Program

Chemical Analysis for Biocompatibility Assessment of Medical Devices

Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle

Basic Safety and Essential Performance of Medical Electrical Equipment — ASCA Program

Global Unique Device Identification Database (GUDID)

Premarket Approval Application and Humanitarian Device Exemption Modular Review

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J

Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations

Electronic Submission Template for Medical Device Q-Submissions

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