Major regulatory issues that may impact medical device companies.
Please contact Helen Simons, 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FDA Draft Guidance on Categorization of IDE Devices to Assist CMS with Coverage Decisions
FDA CDRH issues draft guidance “List of Highest Priority Devices for Human Factors Review”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StarFish Analysis: Draft Guidance on Interoperable Medical Devices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 announces FY 2016 proposed guidance development and focused retrospective review of final guidance
StarFish Analysis: Impact of Health Canada plans to phase out the CMDCAS program and transition to MDSAP
FDA NEWS: Functional Equivalence of Transition Tyvek
FDA: Seven New Medical Device Education Modules on CDRH Learn website
StarFish Analysis: IMDRF Seeks Participation in Voluntary Regulatory Submission Pilot Program
FDA Publishes Medical Device User Fees for 2016
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)
StarFish Analysis: Medical device accessory draft guidance
Official Database of FDA Guidance Documents and other regulatory guidance
StarFish Analysis: Great News for Medical Device Accessories and products intended for general wellness!
CDRH FY 2015 Proposed Guidance Development and Focused Retrospective Review of Final Guidance AND Website Improvements for Industry Education
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
(Final) “In Vitro Companion Diagnostic Devices”, UCM262327, issued Aug 6, 2014 by CBER, CDRH and CDER
(Final) “Design Considerations for Devices Intended for Home Use”, UCM331681, issued Aug 5, 2014 by CDRH and CBER
(Draft) “Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements”, UCM407292, issued Aug 1, 2014, by CDRH
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k) UCM284443, issued Jul 28, 2014 by CDRH and CBER
Medical Device Data Systems (MDDS), Medical Image Storage Devices, and Medical Image Communications Devices
FDA Releases Draft Long-Sought Twitter Guidance
Medical Device Single Audit Program (MDSAP)
Federal Register: Global Unique Device Identification Database
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