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.

American Guidelines

Clinical guidelines, regulatory resources, and compliance tools

221 resources

All American Guidelines 221 Cardiology & Vascular 19 Dermatology & Venereology 7 Endocrinology, Diabetes & Metabolism 20 Eye, ENT & Neurosensory 7 Gastroenterology & Hepatology 47 Imaging & Radiology 5 Infectious Diseases & Microbiology 13 Internal Medicine & Emergency 4 Medical Technology & Engineering Neurology & Neurosurgery 12 Oncology & Haematology 33 Paediatrics 6 Public Health & Primary Care 8 Rehabilitation & Geriatrics 4 Respiratory & Intensive Care 8 Rheumatology & Immunology 11 Surgery & Orthopaedics 5 Umbrella & Cross-Cutting Women's Health & Obstetrics 12

221 resources

ACR Appropriateness Criteria: Chest Pain — Suspected Acute Coronary Syndrome

Clinical Guideline 2022 American Guidelines Imaging & Radiology

Clinical Guideline by ACR-RAD in Imaging & Radiology (2022).

American Guidelines

ACR Appropriateness Criteria: Chest Pain — Suspected Acute Coronary Syndrome

ACIP Recommended Immunization Schedule for Children and Adolescents

ACR Appropriateness Criteria: Breast Cancer Screening

ACEP Clinical Policy: Management of Acute Headache in the Emergency Department

ACIP Recommended Immunization Schedule for Adults

AAP Guideline: Screening for Childhood Obesity

AAP Clinical Practice Guideline: Management of Bronchiolitis in Infants

AAP Guideline: Management of Neonatal Jaundice in Infants ≥35 Weeks

AAP Clinical Practice Guideline: Evaluation and Management of ADHD in Children

AAP Clinical Practice Guideline: Evaluation and Management of Febrile Infants 8-60 Days

AAP Clinical Practice Guideline: Diagnosis and Management of Acute Otitis Media

AAOS Clinical Practice Guideline: Management of Osteoarthritis of the Knee (Non-Arthroplasty)

AAOS Clinical Practice Guideline: Management of Rotator Cuff Injuries

AAO-HNS Clinical Practice Guideline: Tonsillectomy in Children

AAOS Clinical Practice Guideline: Management of Hip Fractures in Older Adults

AAO-HNS Clinical Practice Guideline: Adult Sinusitis

AAO-HNS Clinical Practice Guideline: Sudden Hearing Loss

AAO Preferred Practice Pattern: Primary Open-Angle Glaucoma

AAO Preferred Practice Pattern: Cataract Surgery

AAO Preferred Practice Pattern: Diabetic Retinopathy

AAD-NPF Joint Guidelines of Care for Psoriasis: Overview and Psoriatic Arthritis

AAO Preferred Practice Pattern: Age-Related Macular Degeneration

AAD Guidelines for Management of Melanoma: Primary Cutaneous Melanoma

AAD-NPF Joint Guidelines of Care for Psoriasis: Biologics Treatment

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