FDA Open To Home COVID-19 Testing With Caveats, OIVD’s Stenzel Says

The US FDA is open to the idea of home-testing for the COVID-19 virus, but only after making sure the test is completely safe and effective, and available only through a physician’s oversight, said Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health.

Sample blood test of Coronavirus (Covid-19) on hand with black glove, Coronavirus Covid 19 infected blood sample in sample tube in hand of scientist doctor biohazard protection coronavirus, positive

[Editor’s note: This article was updated on 7 April to clarify the regulatory status of the Becton Dickinson/BioMedomics serology COVID-19 test.]

More from Regulation

Commission Needs To Prioritize Devices Agency Above All Else

 

Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.

Draft FDA Reorganization Would Unite All Product Centers

 

Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.

End Of The Road? Court LDT Decision May Leave FDA With Few Options

 

Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?

Pushing On An Open EU Door? Time For MHRA To Get Practical About UK’s Regulatory Ambition

 
• By 

The UK’s “New Approach” to regulation has created a lot of noise, but what’s the end product? asks Taylor Wessing partner Alison Dennis, who says the UK medtech regulator should look afresh at the EU’s ready-made solution.

More from Policy & Regulation

Shuren Expects Longer CDRH Review Times

 
• By 

The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.

Draft FDA Reorganization Would Unite All Product Centers

 

Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.

End Of The Road? Court LDT Decision May Leave FDA With Few Options

 

Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?