US FDA Final Guidance – Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
Published in Benefit-Risk Determination, Guidance and United States Food and Drug Administration - US FDA
More from Benefit-Risk DeterminationMore posts in Benefit-Risk Determination »
- USA – Public Workshop – Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond
- Final guidance – GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties
More from GuidanceMore posts in Guidance »
- EU – MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
- EU – Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
- US – FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19
- UU – Final guidance – Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
- US Final Guidance – Bone Anchors – Premarket Notification (510(k)) Submissions
More from United States Food and Drug Administration - US FDAMore posts in United States Food and Drug Administration - US FDA »
- EU – Team-NB Position Paper on Documentation Requirements for Drug Device Combination Products Falling in the Scope of Article 117 of MDR 2017/745.
- US – FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19
- US – Ventilator Supply Mitigation Strategies – Letter to Health Care Providers
- US – Update on the Ethylene Oxide Sterilization Master File Pilot Program
- US – FDA Engagement to Mitigate Potential Shortage of Personal Protective Equipment (PPE)
Be First to Comment