Newsletter - October 5, 2023
FDA Again Tries to Regulate LDTs: This Time It Will Work, Unless….
For the last 15 years, the FDA’s attempts to regulate Lab Developed diagnostic Tests (LDTs) were rebuffed due to the lack of political will for such regulation or public support. FDA unsuccessfully tried to get Congress to pass new LDT laws, and its proposed guidance documents to regulate LDTs were derailed by...Read More
No More Paper 510k Submissions to the FDA
Starting October 1, 2023, FDA no longer accepts paper 510k submissions. As announced before, 510k applications must be created using the eSTAR template and submitted electronically to the FDA for review. This week FDA released the final guidance for the electronic submission of 510k applications...Read More
FDA Again Tries to Regulate LDTs: This Time It Will Work, Unless….
For the last 15 years, the FDA’s attempts to regulate Lab Developed diagnostic Tests (LDTs) were rebuffed due to the lack of political will for such regulation or public support. FDA unsuccessfully tried to get Congress to pass new LDT laws, and its proposed guidance documents to regulate LDTs were derailed by...Read More
No More Paper 510k Submissions to the FDA
Starting October 1, 2023, FDA no longer accepts paper 510k submissions. As announced before, 510k applications must be created using the eSTAR template and submitted electronically to the FDA for review. This week FDA released the final guidance for the electronic submission of 510k applications...Read More
