Extension of Special Certification Validity for COVID-19 Test Kits
Last 24 September 2021, the six months additional validity of issued special certifications for COVID-19 Test kits brought by FDA Memorandum No. 2021-009 has already expired. The regulation set minimum performance requirements for these products and designated the Research Institute for Tropical Medicine (RITM) to conduct the evaluation. With new issuance, FDA Circular No. 2021-023, the validity of said certifications was further extended to 31 December 2021 provided the following conditions are met:
1. The market authorization holder (MAH) already filed for the re-issuance of the special certificate on or before 23 September 2021.
2. The MAH is only waiting for result of the technical evaluation from RITM.
All authorizations that were not submitted with application for re-issuance on or before 23 September 2021 and/or failed the technical performance evaluation of RITM are now considered revoked or canceled.
RITM and FDA continues to publish results of recently concluded technical evaluations in their respective websites.
Manufacture of Medical Gases without LTO
In an effort to conquer shortages in medical gases brought by the pandemic, PFDA will not issue regulatory sanctions to manufacturers of medical gases without a valid LTO based on FDA Memorandum 2021-019. The following conditions must be met for this exemption:
1. The establishment already filed an application for LTO.
2. The facility already obtained inspection Certificate of Compliance (COC).
3. Within 60 days after 27 September 2021 or upon issuance of COC, whichever comes first, the facility must already be issued with an LTO.
Interested parties may take advantage of this relaxation as this memorandum is valid while the public health emergency due to the pandemic is still in effect.
FDA Circular No. 2021-023