March 23, 2020
- “FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff” (Issued March 16, 2020) https://www.fda.gov/media/135659/download: This guidance document describes two policies for accelerating the development of certain laboratory tests for COVID-19 – one leading to an Emergency Use Authorization (EUA) submission to the FDA and the other not leading to an EUA when the test is developed under the authorities of the state in which the lab resides and the state takes responsibility for COVID-19 testing by laboratories in its state. This guidance document also describes a policy for commercial manufacturers to more rapidly distribute their diagnostics to laboratories for specimen testing after validation while an EUA is being prepared for submission to FDA. Finally, it also describes FDA’s policy regarding the use of serological testing without an EUA.
- FDA FAQs on COVID-19 Diagnostic Testing (updated as of March 21, 2020) https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2#offerhometest: Questions and answers regarding the new Policy for Diagnostic Tests for Coronavirus Disease-2019 During Public Health Emergency.
- “FDA Policy on Certain REMS During COVID-19 Public Health Emergency: Guidance for Industry and Healthcare Professionals” (Issued March 2020) https://www.fda.gov/media/136317/download: This guidance document communicates FDA’s temporary policy for certain risk evaluation and mitigation strategies (REMS) requirements for the duration of the public health emergency. As is relevant for clinical laboratories, this guidance states that the FDA is relaxing REMS requirements for certain drugs that require laboratory testing (e.g., liver enzyme testing) if there are compelling reasons for a healthcare provider not to complete such tests based on his/her best medical judgment (e.g., if a patient has been exposed to COVID-19, is in self-isolation, or quarantine). REMS requirements will remain in effect, but FDA does not intend to take enforcement actions against sponsors or others for accommodations made regarding lab testing requirements during this public health emergency, provided such accommodations were made based on the judgement of a healthcare professional. (Note that this guidance also applies to REMS with imaging requirements (e.g. magnetic resonance imaging).
- FDA Statement Regarding Unauthorized Fraudulent COVID-19 Test Kits (Issued March 20, 2020) https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits: FDA’s press release regarding unauthorized fraudulent test kits that are being marketed to test COVID-19 in the home. At this time, FDA has not authorized any test that is available to purchase for testing oneself at home for COVID-19.
State Level Guidance and Press Releases
As of March 23, 2020, three states are conducting their own COVID-19 testing procedures – meaning they are allowing clinical laboratories licensed within the state to validate and distribute COVID-19 diagnostic tests without an EUA from FDA. These states are New York, Washington, and Nevada. The state level policies do not appear to be publicly available at this time, but FDA did issue a press release on March 13, 2020 regarding its decision to exercise enforcement discretion in not objecting to New York State Department of Health authorizing certain laboratories in New York to begin patient testing after validating their tests and notifying the NYSDOH: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-gives-flexibility-new-york-state-department-health-fda-issues