FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types

Moment, theU.S. Food and Drug Administration streamlined its COVID- 19 test policy to insure uninterrupted access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways. The streamlined policy describes the FDA’s intent to review only a small subset of new exigency use authorization( EUA) requests for individual tests and encourages inventors of all test types interested in marketing authorization to pursue authorization through the de novo bracket or 510( k) concurrencepre-market review pathways.

“ Testing remains one of the crucial pillars in combatting the COVID- 19 epidemic, ” said Jeff Shuren,M.D.,J.D., director of the FDA’s Center for bias and Radiological Health. “ Taking into account the current status of manufacturing capacity and consumer access given the Administration’s important investments in tests, for utmost new tests, shifting to traditional premarket review would best meet the public health requirements at the current stage of the COVID- 19 public health exigency. The FDA will continue to offer support and moxie to help with the development of accurate and dependable tests, and to grease uninterrupted access to tests for all Americans. ”
Since the launch of the epidemic, the FDA has acclimated its nonsupervisory approach to address the public’s testing needs and has worked nearly with test inventors to acclimate as those requirements have changed. These sweats have helped increase testing capacity and broaden public access to rapid-fire tests, including those bought over-the-counter( OTC). TheU.S. presently has the capacity for authorized manufacturers to produce hundreds of millions of tests per month, although the number of tests available for use at any given time will depend on demand and other factors.

To date, further than 430 distinct COVID- 19 tests have been issued EUAs. The available information indicates that these tests are furnishing sufficient testing capacity for COVID- 19 tests throughout the United States. Feting the current testing capacity, at this time, the agency believes most unborn cessions are best suited for traditional premarket review pathways. thus, the FDA is revising its policy to modernize the types of COVID- 19 tests for which the agency intends to review EUA requests and bandy the use of the traditional premarket review pathways for COVID- 19 tests. Tests for which EUA authorization requests are pending previous to this advertisement will remain in the line.
Moving forward, the FDA generally intends to concentrate its review on EUA requests and supplemental EUA requests from educated inventors for

individual tests that are likely to have a significant benefit to public health( similar as those that employ new technologies);
individual tests that are likely to fulfill an unmet need( similar as diagnosing infection with a new variant or subvariant);
Supplemental EUA requests for preliminarily authorized tests when the request is intended to fulfill a condition of authorization or includes a revision that will significantly profit public health or fulfill an unmet need; and
Tests for which the EUA request is from( or supported by) aU.S. government stakeholder, similar as tests funded by the Biomedical Advanced Research and Development Authority( BARDA) or the National Institutes of Health’s Rapid Acceleration of Diagnostics( RADx).
The FDA believes these precedences are applicable to address the public health requirements at the current stage of the COVID- 19 public health exigency and may acclimate these precedences as public health needs change. The FDA encourages test inventors to consider these precedences and to else shift their focus to traditional premarket review pathways for tests formerly authorized under EUA and new tests of the same types as those formerly available under EUA.
To date, the agency has eased the traditional premarket review of COVID- 19 individual tests, one through de novo bracket and others of the same type exercising the 510( k) concurrence process.

Affiliated Information
Policy for Coronavirus Disease- 2019 Tests During the Public Health Emergency( Revised)
FAQs on Testing for SARS- CoV- 2

The FDA, an agency within theU.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of mortal and veterinary medicines, vaccines and other natural products for mortal use, and medical bias. The agency also is responsible for the safety and security of our nation’s food force, cosmetics, salutary supplements, products that give off electronic radiation, and for regulating tobacco products.

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