Smith Associates

News & Information

• Press Release MedMira recieves approval for new rapid HIV test, United Press International, FDA Premarket Approval Information
• Medical Product Outsourcing “Companies of All Sizes Depend on Regulatory Firms to Meet a Plethora of Needs, by: Andy Teng”Move to Regulatory Outsourcing
• Draft Guidance: The Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval
• Guidance on Quality System Regulation Information for Various Pre-Market Submissions
• Guidance on Quality System Regulation Information for Various Pre-Market Submissions
• General Principles of Software Validation; Draft Guidance
• Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
• FDA Recognized Consensus Standards
• Sterility Review Guidance
• Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices