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Future PCCP Training Coming In Finalized Documents, FDA DHCoE Deputy Director Says

Future PCCP Training Coming In Finalized Documents, FDA DHCoE Deputy Director Says

 
• By Hannah Daniel

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.

CDRH On Track To Meet All MDUFA V Goals

CDRH On Track To Meet All MDUFA V Goals

 
• By Hannah Daniel

CDRH is on track to meet its MDUFA V goals, seeing a steady return to pre-pandemic levels of device authorizations and submissions.

Rulemaking Can Only Do So Much: Stakeholders Weigh In On LDT Rule

Rulemaking Can Only Do So Much: Stakeholders Weigh In On LDT Rule

 
• By Hannah Daniel

Investors and business executives weighed in on the FDA’s proposed rule on LDTs during a panel at the Medtech Conference on 9 October. 

Diagnostics Have Evolved, So Too Has the VALID Act, Says FDA’s Hillebrenner

Diagnostics Have Evolved, So Too Has the VALID Act, Says FDA’s Hillebrenner

 
• By Brian Bossetta

As diagnostics have become more technologically advanced and are used more frequently in detecting diseases, uniform regulatory standards have become necessary, according to a panel of experts discussing testing reform at the MedTech Conference in Boston.