USFDA news and notes
Innovation Pathway
Regulatory decisions that improve patient access to safe and effective, innovative medical devices, for more information on the FDA’s new approach to device review:
Want answers? Try the FDA/Xavier University seminar on medical devices, 1 – 4 May 2012: http://www.xaviermedcon.com/
New FDA draft Guidance Documents, keep on top of the changes:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm162707.htm
European Union/CE Marking news and notes:
The UK is undertaking a comprehensive review of their regulatory processes. The initiative is called Better Regulation of Medicines Initiative (BROMI) and you can follow their work at:
New members are being sought for the Commission on Human Medicines. To be considered you must be a member of your Royal College. For more information: http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON146607
Australian TGA news and notes:
The Australian TGA posts presentations made by its staff. Recent topics include plant inspections and risk management. http://www.tga.gov.au/newsroom/events-presentations-manuf.htm
Review the new guidance document on the substantiation of indications for use and device claims. http://www.tga.gov.au/industry/cm-evidence-claims.htm
ISO and IEC Standards new and notes:
Having the most recent edition of a reference standard is critical to smooth product testing and regulatory approvals. Care to monitor the international standards development process... check out these features: http://www.iso.org/iso/search/pred_searches.htm for the latest ISO Standards and http://www.iec.ch/dyn/www/f?p=103:109:0 for the latest IEC Standards.