FDA PRESS STATEMENT
11 March 2021
Recognizing the need for immediate access to COVID-19 Rapid Test Kits during the present pandemic, the Food and Drug Administration (FDA) pursued policies allowing importers to immediately place their products in the local market with the least amount of regulatory burden as long as there is evidence of quality and accuracy from foreign FDA counterparts. The FDA is one of the government agencies who responded to the Republic Act 11469 otherwise known as “Bayanihan to Heal as One Act”, particularly on Section 4 (b) “Expedite and streamline the accreditation of test kits…”
One of the policies introduced during the current public health emergency is to require performance testing of COVID-19 Rapid Test Kits as a post authorization commitment. Performance testing is a process in which product specifications pertaining to clinical sensitivity and clinical specificity are validated by a reference laboratory, in this case the Research Institute of Tropical Medicine (RITM).
During normal times, results of performance testing are required by FDA prior to issuance of a marketing authorization. This entails huge costs, longer time and must be carried out by a national reference laboratory who has the capacity to perform such test. Considering the urgent need for access to test kits in light of the COVID-19 pandemic, the limited capacity of the RITM to validate new technologies, and in compliance with the provisions of the Bayanihan Act, the FDA required the validation only after market approval.
An arrangement was made with the RITM that all FDA certified COVID-19 Rapid Test Kits shall be referred to said Institution for the conduct of performance validation. As regards COVID-19 Rapid Test Kits which significantly performed below the declared sensitivity and specificity based on the findings of RITM, letters have been issued directing the immediate cessation of selling activities. The RITM posted the results in their website for appreciation of the public. Respective companies were also required to explain the results of the testing. In the meantime, the FDA is already initiating the process for the eventual recall of the affected products.