Evaluation of automatic class III designations for MSK-IMPACT

Abstract:

FDA unveils streamlined path for the authorization of tumor profiling tests alongside its latest product action.

Type:

Report

Date:

2017

Authors and Contributors:

US Food and Drug Administration

Site link:

URL Citation:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN170058

Notes:

After clicking the site link, scroll down and select Decision Summary.

LawSeq^SM Record Last Modified:

05/14/2026