Electronic Submissions of De Novo Applications Required in 2025
Starting October 2025, the U.S. Food and Drug Administration (FDA) will require all De Novo classification requests to be submitted electronically, via the electronic Submission Resource and Resource (eSTAR) template, marking a significant shift in regulatory submission processes for medical devices. This transition aims to streamline the approval process and enhance the efficiency of device […]
PCCP Draft Guidance Released by FDA
The U.S. Food and Drug Administration (FDA) has officially released its highly anticipated guidance on Pre-Determined Change Control Plans (PCCPs)for medical devices. This new framework is set to streamline regulatory processes and enhance flexibility for device manufacturers, offering a structured approach to managing modifications to approved devices. PCCPs represent a significant shift in how manufacturers […]
TGA Seeks to Align Essential Principles with EU Regulations
In a bid to harmonize regulatory practices and streamline the approval process for medical technologies, the Therapeutic Goods Administration (TGA) has initiated a consultation to align Australian Essential Principles with European Union (EU) Regulations’ General Safety and Performance Requirements (GSPR). This move marks a significant step toward improving market access, ensuring safety, and fostering innovation […]
EMA Launches a Pilot Program on Orphan Medical Devices
In a significant move to address a critical gap in the healthcare industry, a new pilot program has been launched to support orphan medical devices. On August 2, 2024, the European Medicines Agency (EMA) announced that its effort, as mandated under Regulation (EU) 2022/123 (Regulation – 2022/123 – EN – EUR-Lex (europa.eu)), aims to provide […]
