FDA task force to enhance regulation of medical devices

CEBU, Philippines — The country's Food and Drug Administration (FDA) has established Task Force Obsidian, a technical working group (TWG) aimed at enhancing the regulation of medical devices.

This initiative underscores the FDA's commitment to safeguarding public health and enforcing strict regulatory standards.

Task Force Obsidian will bolster the agency's administrative and technical capacity to regulate health products and establishments within its jurisdiction, in line with Republic Act No. 9711.

The task force is responsible for developing clear and comprehensive policies and guidelines for the classification of medical devices submitted for FDA approval.

"This initiative aims to ensure that all devices are thoroughly and accurately classified according to their risk, use, and safety, thus fortifying the integrity of the FDA s regulatory framework," the FDA stated.

As a result, FDA issuances on device classification are expected to become more authoritative, while the application process will be streamlined. Task Force Obsidian will also assess potential risks in the implementation of these policies and proactively recommend corrective measures to ensure compliance.

Regular updates will be provided directly to the Office of the Director General. — /LPM