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

USPSTF Recommendation: Screening for Type 2 Diabetes

Clinical Guideline 2021 American Guidelines Medical Guidelines & Recommendations

Clinical Guideline by USPSTF in Public Health & Primary Care (2021).

American Guidelines

USPSTF Recommendation: Screening for Type 2 Diabetes

USPSTF Recommendation: Screening for Depression in Adults

USPSTF Recommendation: Screening for Lung Cancer

USPSTF Recommendation: Screening for Cervical Cancer

USPSTF Recommendation: Screening for Colorectal Cancer

USPSTF Recommendation: Screening for Breast Cancer

Endocrine Society Guideline: Treatment of Hypothyroidism in Adults

SAGES Guideline: Laparoscopic Appendectomy

Endocrine Society Guideline: Pharmacological Management of Osteoporosis in Postmenopausal Women

Endocrine Society Guideline: Testosterone Therapy in Men with Hypogonadism

Endocrine Society Guideline: Management of Pheochromocytoma and Paraganglioma

Endocrine Society Guideline: Management of Thyroid Dysfunction During Pregnancy

ATA Guidelines: Management of Thyroid Cancer

AHA Guidelines: Pediatric Advanced Life Support (PALS)

AHA Guidelines: CPR and Emergency Cardiovascular Care

AGS/BGS Clinical Practice Guideline: Prevention of Falls in Older Persons

AHA Guidelines: Advanced Cardiovascular Life Support (ACLS)

AGS Guidelines: Persistent Pain in Older Persons

AGS Beers Criteria: Potentially Inappropriate Medication Use in Older Adults

AGS Guideline: Postoperative Delirium in Older Adults

ACR Practice Parameters: CT of the Head (Adult)

ACS TQIP Best Practice Guidelines: Geriatric Trauma Management

ACR Appropriateness Criteria: Headache

ACR Appropriateness Criteria: Low Back Pain

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