CDRH Dx Office Integrates 30-Day Quick-Reviews Into 510(k) Program
This article was originally published in The Gray Sheet
Executive Summary
Following a successful 30-day review pilot last fall, CDRH’s diagnostics office started incorporating the quick-review process into its overall 510(k) review program in January. The Office of Device Evaluation is considering following suit.
You may also be interested in...
OIVD Becomes OIR: FDA Diagnostic Office Adds Entire Radiological Health Program
The agency has fully incorporated all of its post-market radiological health regulatory programs into its newly-named Office of In Vitro Diagnostics and Radiological Health.
The 12%: Diagnostics “Quick Reviews” Make A Mark, FDA Official Says
The first month of the diagnostics office’s “triage” pilot program has led to quicker reviews for some 510(k)s, an agency official reports. To qualify for the program's quick-review pathway, a submission must be of high quality and free of certain time-consuming complexities.
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.