There are number of conflated regulatory problems in this piece:
1) FDA needs to move its data ingestion into the 21st century (note: large industry can be as resistant to changing current process as bureaucracy). In no rational universe should we have to mail data in 2020
2) In vitro diagnostic regulation is a mess and needs to be revamped top to bottom. Either exempt all Lab Developed Tests, rewrite the law to make them all subject to oversight, or come up with a 3rd path.
3) Emergency Use Authorization needs to be rethought with the ability for either political leadership or FDA to have broad capability to expand the category of what gets covered
1) FDA needs to move its data ingestion into the 21st century (note: large industry can be as resistant to changing current process as bureaucracy). In no rational universe should we have to mail data in 2020
2) In vitro diagnostic regulation is a mess and needs to be revamped top to bottom. Either exempt all Lab Developed Tests, rewrite the law to make them all subject to oversight, or come up with a 3rd path.
3) Emergency Use Authorization needs to be rethought with the ability for either political leadership or FDA to have broad capability to expand the category of what gets covered