Compliance Corner

• A change to AAMI/ISO 11737-2 affects the Bacteriostasis/Fungistasis test
• AAMI Working Group 2 for Radiation Sterilization publishes new TIR 40:2009
• Recent views from the FDA on Gentoxicity testing
  • Source: FDA.gov
• FDA to test BPA Exposure from medical devices
  • Medpagetoday.com
• "Be in the Know about EtO: Expedited processing and better controls amp up the efficiency of ethylene oxide sterilization while revised standards affect validation"
  • Source MPMN, May 2009
• "FDA Recommendations to Industry Regarding Outsourcing: How to ensure compliance in the outsourcing environment" 
  • Source: BioPharm International.com, April 2009 
• "Benefits of Effective Communication with a Contract Analytical Laboratory: How to handle out-of-specification results in contract analytical work."
  • Source: BioPharm International.com, April 2009
• "Following the Road to Regulation:  FDA's goal is to address the gaps in regulatory oversight of certain diagnostic assays."
  • Source: MDDI, February 2010
• FDA Inspections for 21 CFR 111 (Dietary Supplements) will become common
  • Souce:  Labcompliance News.com