CDRH touts lack of application backlog
The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) announced this month that for the second year in a row, its premarket review program had no backlog of 510(k)s, premarket approval applications, or PMA supplements
The Food and Drug Administrations Center for Devices and Radiological Health (CDRH) announced this month that for the second year in a row, its premarket review program had no backlog of 510(k)s, premarket approval applications, or PMA supplements for fiscal year 1998.
Average total review time for 510(k) applications was 114 days an improvement over 130 in 1997 and 145 in 1996. Median review time for 510(k)s that cleared in fiscal year 1998 was 83 days. CDRH cleared 46 PMAs in 1998, according to the agency. The average review time of PMAs from submission to approval was roughly 12 months, 25% less than fiscal year 1997 and 50% less than fiscal year 1996. The median total time the CDRH took to clear PMAs in 1998 was about nine months.
The program attributed improved clearance times to more companies consulting with the FDA as they plan clinical studies. They also credited pilot management initiatives the CDRH implemented this year.
Considering Breast- and Lesion-Level Assessments with Mammography AI: What New Research Reveals
June 27th 2025While there was a decline of AUC for mammography AI software from breast-level assessments to lesion-level evaluation, the authors of a new study, involving 1,200 women, found that AI offered over a seven percent higher AUC for lesion-level interpretation in comparison to unassisted expert readers.
