The Food and Drug Administration (FDA) is mandated to issue standards and appropriate marketing authorizations (MAs) to all its covered establishments, facilities, and health products. Through this endeavor, the FDA developed the eServices Portal System as an online platform that caters to the application of certain MAs including the License to Operate (LTO) for Retailers of Medical Devices. Relative to this, the FDA drafted a policy entitled, “Guidelines on the Use of the Food and Drug Administration eServices Portal System for License to Operate (LTO) Application of Retailers of Medical Devices” that intends to provide procedural guidelines on the use of the FDA eServices Portal System, identify the establishments that shall be covered by the policy, and execute its nationwide implementation.
In the interest of service and to seek the inputs of Stakeholders, the FDA is respectfully inviting one (1) representative of each company/organization from the medical device industry to attend the Virtual Public Hearing scheduled on 29 July 2022 via Google Meet. Eighty (80) slots have been allotted to those interested participants. The registration is accessible through this link https://forms.gle/HaWiEVH4amw7uYME6.
Further, provided herewith the copy of the draft FDA Circular for reference.
Thank you very much.