FDA forms Task Force Obsidian to regulate medical devices

The Food and Drug Administration (FDA) has established Task Force Obsidian to enhance regulation of medical devices in the Philippines.

Task Force Obsidian aims to help stakeholders correctly classify medical devices, develop clear policies and guidelines, and streamline the application process based on the ASEAN Medical Device Directive.

FDA spokesperson Pamela Sevilla emphasized during a Bagong Pilipinas Ngayon interview that compliance with these regulations is crucial for stakeholders who are often unsure about the correct classification of their devices.

Sevilla noted that improperly classified medical devices may not have undergone FDA approval, posing risks to consumers who purchase them.

The task force will also assess potential risks and recommend corrective actions to ensure compliance with regulations, while conducting information dissemination to educate clients and applicants.

Regular updates on Task Force Obsidian's progress will be provided directly to the Office of the Director General.