MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
Posts tagged as “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
Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices
CDRH Proposed Guidances for Fiscal Year 2020 (FY 2020)