FDA Open To OTC Sale Of COVID-19 At-Home Sample Collection Kits

FDA is open to authorizing COVID-19 at-home sample collection kits for over-the-counter use, as long as sponsors demonstrate consumers can easily use the tests and interpret results without oversight by a health care professional, an agency official told stakeholders during FDA’s Virtual Town Hall on Wednesday (May 20). The agency’s acknowledgement that it supports OTC tests comes as the Government Accountability Office says FDA approval of more at-home sample collection kits could help expand test access. Currently, consumers must be...