This is to inform all concerned stakeholders that FDA Advisory No. 2021-2634 entitled, “Pilot Implementation of Food and Drug Administration eServices Portal System for License to Operate Application of Retailers of Medical Devices within the National Capital Region” issued on 02 November 2021 is hereby extended until further notice.
Once the eServices Portal System is fully operational, all Medical Device Retailers outside of the NCR may then apply for LTO with the FDA. The FDA will release a separate issuance to all stakeholders to coincide for the nationwide implementation.
For concerns, you may contact the FDA Food and Drug Action Center at the following numbers:
(8) 857-1900 local 1000 / (8) 842-5635
0961-0574926 / 0961-7709691 / 0961-6845994
For information and guidance.