RESOLUÇÃO – RDC Nº 305, DE 24 DE SETEMBRO DE 2019 – Dispõe sobre requisitos para fabricação, comercialização, importação e exposição ao uso de dispositivos…
Medical Device Expert News
There’s a bit of discussion in Elsmar about EU MDR Classification Rule 11. – Please explain MDR Rule 11 to me. Please feel free to…
CDRH’s Health of Women Program Strategic Plan
Frequently Asked Questions (FAQs) About the Accreditation Scheme for Conformity Assessment (ASCA) Pilot
Patient Engagement in Design and Conduct of Medical Device Clinical Investigations
Draft Guidance on Accreditation Scheme for Conformity Assessment (ASCA) Pilot
Collaborative Communities: Addressing Healthcare Challenges Together Webinar: Collaborative Communities – October 29, 2019 FDA in Brief: FDA announces participation in first two ‘Collaborative Communities’ working…
Regulating medical devices in the event of a no-deal Brexit
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…