The Center for Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (FDA) will be conducting an inventory and processing of the pending applications for registration of medical devices. As such the period of December 15, 2023 to January 15, 2024 is hereby declared as an Application holiday. This will enable the CDRRHR to catch up with the back log/pending applications.
For the abovementioned purpose, the FDA shall not receive the CMDN applications filed through the eService portal.
Notwithstanding the foregoing, the CDRRHR shall continue to accept the following types of product registration applications:
- CMDR Initial application filed through the email cdrrhr- [email protected]
- Renewal applications.
- Variation applications
- Other authorizations (Covid Special Certificate, Certificate of Free Sale, Promo Permit CMDL and Clearance for Customs Release
Moreover, pre-assessment of applications which has already been scheduled by the CDRRHR may proceed but the payment and endorsement of accepted applications to the CDRRHR shall resume after the application holiday.
For information and guidance of all concerned.