FDA Announces Opening of FY2027 MDUFA Small Business Determination Window
FDA opens the FY2027 MDUFA Small Business Request window on August 1, 2026. Learn eligibility rules, user fee discounts, and submission steps.
FDA CBER Updates SOPP on MDUFA User Fee Payments and Billing Activities
FDA CBER has updated SOPP 8704 on MDUFA user fee payments and billing activities, including electronic payments, payment verification, user fee holds, refunds and establishment registration fees.
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 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.
FDA Strengthens Manufacturer Interactions Program: New Guidance on the Q-Submission Program
The FDA 's new guidance on the Q-Submission Program offers practical guidelines for manufacturers who intend to request formal feedback or technical meetings during the planning or review of regulatory submissions for medical devices and IVDs.