Four More Guidance Documents Released: Antimicrobial Devices, Closed-Loop Control Technology, De Novo Submissions, Devices For Graft Versus Host Diseases
Executive Summary
The US FDA recently published four guidance documents, two final — one concerning antimicrobial susceptibility test system devices and another related to devices with physiologic closed-loop control technology. The agency’s two draft documents pertain to electronic submissions for de novo requests and graft-versus-host diseases.
You may also be interested in...
Future PCCP Training Coming In Finalized Documents, FDA DHCoE Deputy Director Says
The AI/ML pre-determined change control plan final guidance will include plans for agency-wide training for the implementation of PCCPs, an FDA deputy director said at the Medtech Conference.
Cybersecurity Expert Says eSTAR Requirement Will Push FDA, Industry In Positive Direction
Medcrypt cybersecurity expert tells Medtech Insight that FDA requirements that launch on 1 October will push the industry as well as the agency in a positive direction.
Expert: FDA’s Highly Anticipated PCCP Guidance Isn’t Anything Too ‘Surprising’
The FDA’s highly anticipated predetermined chance control plan (PCCP) guidance document is pretty much what the industry expected, Sidley Austin partner Deeona Gaskin told Medtech Insight.