MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
Posts published in “Guidance”
Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
Bone Anchors – Premarket Notification (510(k)) Submissions
FDA Issues Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
Researcher considerations for medical devices – Meeting the evidence requirements for market authorisation
US – Updated Guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug…