FDA Updates eSTAR Program: Human Factors Content Added and Expanded PreSTAR Functionality
The FDA has released eSTAR Version 7.0, integrating new Human Factors content and expanding PreSTAR capabilities. Learn how these changes may affect medical device manufacturers preparing FDA submissions.
FDA Establishes Class II Classification for TENS Devices Intended to Reduce Fibromyalgia Symptoms
FDA has established a new Class II classification with special controls for transcutaneous electrical nerve stimulators (TENS) intended to treat fibromyalgia symptoms, creating a new regulatory pathway for manufacturers.
FDA Finalizes Risk-Based Guidance on Human Factors Information in Medical Device Submissions
The FDA has published its final guidance on Human Factors information in medical device submissions, introducing a new risk-based framework and three Human Factors Submission Categories. Learn what manufacturers need to know.
FDA Updates Recognized Biocompatibility Standards – Recognition List No. 065
FDA Recognition List 065 updates biocompatibility standards, including ISO 10993-4 Amendment 1 and multiple ASTM revisions. Impact for manufacturers.
FDA atualiza orientações sobre qualificação de Pequenas Empresas no âmbito do MDUFA: Oportunidade estratégica para fabricantes
A FDA publicou uma nova orientação para a qualificação como pequena empresa no âmbito do MDUFA, permitindo a fabricantes de dispositivos médicos e IVDs acederem a reduções nas taxas regulamentares, incluindo submissões 510(k), PMA e De Novo.