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

ASCO Guideline: Treatment of Patients With Early-Stage Colorectal Cancer

Clinical Guideline 2022 American Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ASCO in Oncology & Haematology (2022).

American Guidelines

ASCO Guideline: Treatment of Patients With Early-Stage Colorectal Cancer

ASCO Guideline: Treatment of Small-Cell Lung Cancer

ASCO Guideline: Treatment of Pancreatic Cancer

ASCO Guideline: Treatment of Metastatic Renal Cell Carcinoma

ASCO Guideline: Treatment of Ovarian Cancer

ASCO Guideline: Treatment of Endometrial Cancer

ASCO Guideline: Treatment of Hepatocellular Carcinoma

ASCO Guideline: Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer Without Driver Alterations

ASCO Guideline: Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations

ASCO Guideline: Systemic Therapy for Metastatic Colorectal Cancer

ASCO Guideline: Sentinel Lymph Node Biopsy for Patients With Early-Stage Breast Cancer

ASCO Guideline: Systemic Therapy for Gastric/Gastroesophageal Junction Cancer

ASCO Guideline: Molecular Testing for Selection of Patients With Lung Cancer for Treatment With Targeted Therapy

ASCO Guideline: Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer

ASCO Guideline: Management of Stage IV Breast Cancer

ASCO Guideline: Management of Chronic Lymphocytic Leukemia

ASCO Guideline: Management of Muscle-Invasive Bladder Cancer

ASCO Guideline: Management of Cancer-Associated Venous Thromboembolism

ASCO Guideline: Management of Cancer Pain

ASCO Guideline: Integration of Palliative Care Into Standard Oncology Care

ASCO Guideline: Management of Advanced Prostate Cancer

ASCO Guideline: Cervical Cancer Screening and Prevention

ASCO Guideline: Initial Management of Newly Diagnosed Hodgkin Lymphoma

ASCO Guideline: Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer

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