The Food and Drug Administration through Center for Device Regulation, Radiation Health and Research sought to re-engineer and streamline its authorization processes to establish a more efficient way in government service delivery. As part of these efforts, the FDA through Department of Health (DOH) Administrative Order (AO) No. 2020-0035 or the “Rules and Regulations on the Licensing and Registration of Radiation Facilities Involved in the Use of Radiation Devices and Issuance of Other Related Authorization” adopted a new online authorization process for radiation facilities under its jurisdiction through the FDA RRD Portal.
The FDA invites radiation facilities to participate in the online cascading and pilot implementation of the RRD Portal for the issuance of License to Operate (LTO) and Certificate of Facility Registration (CFR) for Radiation Facilities.
| Online Cascading | October 28, 2020 |
| Participants | Only 300 participants on a first come first served basis via Zoom will be accommodated. Strictly one (1) participant per company/facility.
You may register, through this link https://forms.gle/NdWvigqdZ7N2hJNU9 |
| PILOT IMPLEMENTATION OF FDA RRD PORTAL | |
| Target Participants/ Start of Pilot Implementation | National Capital Region – November 9, 2020
Nationwide – December 9, 2020 |
| Type of Application | Initial and Renewal Application of License to Operate (LTO) and Certificate of Facility Registration (CFR) for Radiation Facilities |
| Fees to be Paid | Based on the Current Schedule of Fees and Charges
(AO No. 29 s. 2000, FDA Circular No. 2011-003, 2011-004) |
| Requirements | In accordance with Annex C and D of AO 2020-0035 |
| Validity of Authorization | In accordance with Section VI of AO 2020-0035
Initial LTO and CFR authorizations shall have three (3) years validity Renewal LTO and CFR authorizations shall have five (5) years validity |
All processes shall be done in accordance to the general and specific guidelines of DOH AO No. 2020-0035.
The detailed step-by-step procedure shall follow the illustrative guide shown in Annex A-C of this Advisory.
Attachment:-> FDA Advisory 2020-1929