Patient Preference Information (PPI) guidance on when and what methods to use to collect and submit patient preference information (PPI) for a device to FDA.
The FDA has updated the CDRH portal to allow users to track the progress of their pre-submissions. As of October 23, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using FDA’s eSTAR portal.
“Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products” and “Artificial Intelligence in Drug Manufacturing” were developed to support the use of AI/ML while addressing concerns related to security, bias and risk, and spur feedback and discussion from stakeholders.
The goal of the TAP Pilot is to reduce the time from concept to commercialization of medical devices by facilitating robust engagement early in the process with the FDA, industry and key stakeholders.
The Experiential Learning Program (ELP) provides CDRH review staff with an opportunity to visit sites and gain a better understanding of the products they review. The 2023 ELP Site Visit Proposal period is open now until September 6, 2022.
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
The center is proposing that Philips repair, replace or refund recalled devices manufactured after November 2015.
The center is also hoping to move back into more normal review timelines next year.
The center is working to address the delays in meeting review timelines for product submissions.
GI Genius is based on machine learning and helps clinicians detect lesions in real time during a colonoscopy.