1 / 14

Medical Device User Fee and Modernization Act

Medical Device User Fee and Modernization Act. Mary Elizabeth Jacobs, Ph.D. Blood Products Advisory Committee June 19,2003. CBER Receipts and Performance. FY 03 Summary at 8 Months (Data to 5/31/03). FY 03 Device Receipts and Performance* (from 10/1/02 – 5/9/03). PMAs (Traditional) 2

oprah
Download Presentation

Medical Device User Fee and Modernization Act

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Medical Device User Fee and Modernization Act Mary Elizabeth Jacobs, Ph.D. Blood Products Advisory Committee June 19,2003

  2. CBER Receipts and Performance FY 03 Summary at 8 Months (Data to 5/31/03)

  3. FY 03 Device Receipts and Performance*(from 10/1/02 – 5/9/03) PMAs (Traditional) 2 PMSs (180 Day) 1 510(k)s (All Types) 36 BLAs (Original, Std) 0 BLSs (Efficacy) 3 BLSs (Manufacturing, PAS) 26 ALL MDUFMA FY 05 GOALS MET. *Data as of 5/09/03

  4. FY 03 Device Receipts and Performance*(from 10/1/02 – 5/31/03) PMAs (Traditional) 2 PMSs (180 Day) 1 510(k)s (All Types) 41 BLAs (Original, Std) 0 BLSs (Efficacy) 3 BLSs (Manufacturing, PAS) 26 ALL MDUFMA FY 05 GOALS MET. *Data as of 5/31/03

  5. 510(k)s ReceivedReceipt Cohort from 10/1/02 – 5/31/03) 510(k) Typen Traditional 26 Abbreviated 6 Special10 Total 42

  6. 510(k)s Received

  7. Time to Final Decision*510(k) Receipt Cohort from 10/1/02 – 5/31/03 FDA Time Total Time 510(k) Typen Av Days**Av days Traditional 17 56.9 58.7 Abbreviated 5 57.2 62.8 Special 9 18.718.7 Total 31 45.9 47.7 * Includes all Final Decisions (SE/NSE/WTH/RTA). **Times may increase with completion of pendings.

  8. CBER 510(k) Cycles(from Receipt to Final Decision*) Final 510(k) TypeDecisionsAverage**Pending Traditional 17 1.12 9 Abbreviated 5 1.20 1 Special91.001 Total 31 1.10 11 *Includes all Final Decisions (SE/NSE/WTH/RTA). **Cycles may increase with completion of pendings.

  9. What improvements led to better performance? • Problem solving • Complete review earlier in cycle, then problem solve • Training • Least Burdensome • Document handling • New courier service for device, CT, and time sensitive documents • New barcode delivery system for documents

  10. New Guidance: Website • Inspection by Accredited Persons Program: Accreditation Criteria • Applies to Class II and III devices • Pediatric Expertise for Advisory Panels • Premarket Approval Application Filing Review

  11. “Blue Book Memos”: Website • Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities • Contact CBER RPM Branch Chief

  12. Expected Reports • Sect. 205 on “timeliness and effectiveness” of reviews by Centers other than CDRH due Oct. 26, 2003 • Annual repot on progress in achieving performance goals report due Nov. 30, 2003

  13. MDUFMA Stakeholder Meeting • December 3, 2003 • Gaithersburg Hilton • After both one year reports • For both CBER and CDRH • Watch Website for more information

  14. Stakeholder input • Electronic docket • Please let us know your concerns • thanks

More Related