Final New 510(k) Paradigm Expected to Reduce Annual 510(k) Volume by Half
This article was originally published in The Gray Sheet
FDA's final new 510(k) paradigm, slated for March publication, is expected to reduce the volume of traditional 510(k) submissions by approximately half of FY 1997's level of 5,049 premarket notifications.
You may also be interested in...
Asking whether FDA’s decision to allow emergency use of two old anti-malarial drugs was ‘political’ misses the point. The issue already was political, and FDA’s action may well be the best way to keep some measure of federal control on supplies of a drug with important other uses.
Guidelines for health care providers could help prevent shortages as demand for possible treatments surge, groups say. Stakeholders also argue “Buy America” executive order would hamper drug access.
BD and BioMedomics have released a new rapid point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19.