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As part of the mandate of the Food and Drug Administration (FDA) to protect public health and safety through regulation of health products, the FDA through the Center for Device Regulation, Radiation Health and Research (CDRRHR) is in the process of developing a policy on the regulation of emerging new in vitro diagnostic medical devices (IVDs).

The CDRRHR has finalized the draft guidelines on the issuance of a Special Certification for the abovementioned IVDs entitled “Requirements for the Issuance of a Special Certification for Emerging New In Vitro Diagnostic Medical Devices Used for Detection and Diagnosis of SARS-CoV-2 Infection”

In the interest of service and to seek the comments of the stakeholders that will be affected by the proposed policy, the FDA is inviting representatives from the IVD industry to attend the Virtual Public Hearing on 18 April 2022 at 9:30 AM to 12:00 PM via Google Meet. Eighty (80) slots have been allotted for those interested to attend the said activity. One (1) representative per company shall be accommodated.

To register and confirm your attendance, please access the link below:

Thank you.