CDRH General Hospital Devices Branch Takes On Software Applications
This article was originally published in The Gray Sheet
Executive Summary
Increased submissions for medically-related software products are prompting CDRH's General Hospital Devices Branch to establish a premarket regulatory framework for the devices
You may also be interested in...
Premarket Guidance Issued For Intravascular Administration Sets
CDRH's guidance on 510(k)s for intravascular administration sets includes a section on microbial ingress testing - a topic CDRH officials have highlighted as an area in need of clarification
Premarket Guidance Issued For Intravascular Administration Sets
CDRH's guidance on 510(k)s for intravascular administration sets includes a section on microbial ingress testing - a topic CDRH officials have highlighted as an area in need of clarification
CDRH Mulls Increased Human Factors Input In Premarket Review Process
CDRH Office of Device Evaluation Director Donna-Bea Tillman, PhD, says she plans to consider whether review staffers need to consult more often with the human factors engineering team