Final and update guidances – Software … the FDA is issuing a final guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the…
Posts tagged as “USFDA”
QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Town Halls Planned
Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act
CDRH’s Health of Women Program Strategic Plan
Patient Engagement in Design and Conduct of Medical Device Clinical Investigations
Collaborative Communities: Addressing Healthcare Challenges Together Webinar: Collaborative Communities – October 29, 2019 FDA in Brief: FDA announces participation in first two ‘Collaborative Communities’ working…
Device Shortages Update – The US FDA Announces Two New Innovation Challenges on Device Sterilization
FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies FDA Innovation Challenge 2: Reduce Ethylene Oxide Emissions
9/13/2019 – Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and FDA Staff 9/13/2019 – Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food…
Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health
Clinical Investigations for Prostate Tissue Ablation Devices