FDA CBER: BECS & Submission types

FDA’s Center for Biologics Evaluation and Research presentation slides from “Computerizing Collection Centers: FDA Submission and Approval ” presented by Nancy Jensen at ABRA Plasma Forum June 11, 1998. Among other things these slides describe CBER’s application of the new 510(k) Paradigm to Blood Bank Computer System Submissions. This includes requirements for abbreviated and special 510(k)s.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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