CDRH And Industry Are Unprepared For Online PMA Submissions
This article was originally published in The Gray Sheet
Executive Summary
FDA has established a single digital entry point for all electronic data submissions to the agency, but CDRH says more logistical work is needed by both manufacturers and the agency before the center can receive premarket applications online
You may also be interested in...
FDA’s “Paperless” System Should Accommodate Variability Of Devices
A "paperless" premarket submissions system for medical devices must be more flexible than the system for drugs, an AGA Medical executive told a panel of FDA and National Institutes of Health officials Dec. 18
FDA’s “Paperless” System Should Accommodate Variability Of Devices
A "paperless" premarket submissions system for medical devices must be more flexible than the system for drugs, an AGA Medical executive told a panel of FDA and National Institutes of Health officials Dec. 18
FDA Seeks Input On Mandatory Electronic Submissions
As FDA looks to enhance its safety surveillance systems, the agency is considering mandatory electronic filing of regulatory submissions