StarFish Analysis: UDI Compliance date, 24 September 2016, fast approaching
Major regulatory issues that may impact medical device companies.
Please contact Helen Simons, Interim StarFish Director of Quality Assurance and Regulatory Affairs, if you would like to discuss implications for your projects.
StarFish Analysis: UDI Compliance date, 24 September 2016, fast approaching
FDA Draft Guidance on Categorization of IDE Devices to Assist CMS with Coverage Decisions
FDA CDRH issues draft guidance “List of Highest Priority Devices for Human Factors Review”
FDA Final Guidance: Applying Human Factors and Usability Engineering to Medical Devices
StarFish Analysis: Draft Guidance on Interoperable Medical Devices
FDA: Seven New Medical Device Education Modules on CDRH Learn website
StarFish Analysis: IMDRF Seeks Participation in Voluntary Regulatory Submission Pilot Program
StarFish Medical Analysis Changes to the Canadian Medical Device Regulations
StarFish Analysis: FDA lists 21 Class III products as reclassification candidates
StarFish Analysis: Health Canada online publication of Regulatory Decision Summaries (RDS)
Official Database of FDA Guidance Documents and other regulatory guidance
Update on UDI Implementation for Registered Medical Device Establishments
StarFish Analysis: Update on IEC60601-1-2 (2014) 4th Edition
StarFish Analysis: July and August 2014 FDA Guidance Documents
Federal Register: Global Unique Device Identification Database