FDA Safety Communication
On January 4, 2021, the FDA issued a Safety Communication about the Curative SARS-CoV-2 Assay.
Here is Curative's response:
Curative’s test has been validated and is being offered during the pandemic under an Emergency Use Authorization, and is labeled with specific warnings, precautions, and limitations that FDA reiterated in the Safety Communication. The test performance and labeling, however, have not changed, nor has the company observed any changes in test performance. We have been working with the agency to address their concerns and these limitations, and we will continue to work interactively with FDA through the Emergency Use Authorization process.
We understand that the Safety Communication seeks to ensure that Curative’s test is administered and performed according to the labeling and limitations in the EUA.
Curative will continue to work actively with FDA to provide additional data required to address the limitations and precautions. Curative remains committed to following FDA and CMS regulations in the development, testing, and use of our Emergency Use Authorized test, and in providing medical devices and services that meet or exceed our customer's expectations operating in accordance with these requirements.
For additional questions on the above or related to your account please contact your account representative. For any patient inquiries related to their test they may contact email@example.com or 888.702.9042.