Appendix 4-CDRH Work Functions.xlsx

This is an appendix detailing the work functions and operational data for the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration, specifically capturing 2025 activities and forecasted 2026 workload metrics.

The document provides comprehensive information about CDRH's three primary work function locations at 8400 Corporate Drive, Suite 500, Landover, Maryland, encompassing approximately 11,000 square feet of space dedicated to Document Control Center (DCC), Registration and Listing, and Radiological Health operations. Key operational metrics include processing of 50 PMA originals with 266 amendments, 4,273 510(k) originals with 988 supplements, 3,624 Q-Submissions originals with 156 amendments, and 348 IDE originals with 156 amendments, among numerous other submission types. The Registration and Listing function handled 21,637 emails annually, assigned 2,800 registration numbers, and processed 26,526 registration confirmation emails. The Radiological Health section managed 4,080 allegations and 1,022 recalls, while imaging operations scanned approximately 59,647 pages from 8,601 electronic documents received in 2025, with a forecasted workload of 8,601 eCopies for 2026. The document also details historical file imaging efforts, including processing of 874 historical files comprising 68,563 pages and 1,022 recall-related documents, providing critical baseline data for the Contractor-Hosted Fully Integrated Records Facility (FIRF) service requirements under the associated IDIQ solicitation.