1. CBER 1 Blood Establishment Computer Software (BECS) Michael Gorman, BA, MT(ASCP)SBB Consumer Safety Officer, CBER, OBRR, DBA September 15, 2009

2. CBER 2 Outline What is a BECS? Regulations for Manufacturers Manufacturers: Medical Device 510(k) Clearance Regulations for Users Validation User Reporting of Implementation CBER 510(k) Cleared BECS Website List References

3. CBER 3 What is a BECS? Medical Device: Medical Device: Defined under the Federal Food, Drug, and Cosmetic Act (FD&C Act) FD&C Act applicability to BECS: Device intended for use either in the: − Diagnosis of disease or other conditions OR − Cure, mitigation, treatment, or prevention of disease in man or other animals

4. CBER 4 What is BECS? (cont.) Part of a computer system used by Blood and Source Plasma establishments, which also includes: − Hardware − SOPs and other documentation − Staff

5. CBER 5 BECS Examples Software Applications Used For: Receiving and storing data for later use during the manufacturing process - examples: − Test results − Donor suitability/eligibility − Blood/blood component suitability – release for transfusion or manufacture into injectable or noninjectable products Computer-assisted self-interview (CASI) donor questionnaires Performing compatibility testing and other transfusion service related functions

6. CBER 6 Regulations for BECS Manufacturers Medical Device Regulations: − 21 CFR 800 to 898 Quality System Regulation (QSR) − 21 CFR 820 Registration: Establishment Registration − 21 CFR 807 Listing the Device: Medical Device Listing − 21 CFR 807 Medical Device Reporting (MDRs) − 21 CFR 803 Labeling − 21 CFR 801

7. CBER 7 BECS Manufacturers: Medical Device 510(k) Clearance Premarket Notification (510k) required under the FD&C Act Allows a medical device, BECS, to be introduced into interstate commerce: − Sold or given away (gratis) interstate − FDA also currently considers interstate data access or transmission to be interstate commerce

8. CBER 8 Regulations for BECS End Users Blood Establishments − 21 CFR 211.68 − 21 CFR 606.100(b)(15) − 21 CFR 606.160(b)(5)(i) − 21 CFR 601.12 Source Plasma Establishments − 21 CFR 606.100(b)(15) − 21 CFR 606.160(b)(5)(i) − 21 CFR 601.12 Voluntary Medical Device Reporting

9. CBER 9 BECS End Users User Site Validation Overview Done outside developer’s controlled environment − 21 CFR 211.68 (Blood Establishments Only) − 21 CFR 606.160(b)(5)(i) − 21 CFR 606.100(b)(15) − General Principles of Software Validation; Final Guidance for Industry and FDA Staff (1/11/2002) Can be performed by: − End user − Third party (consultants) − Developer/manufacturer

10. CBER 10 BECS End Users User Site Validation Overview (cont.) Perform at locations where the software is implemented (installed) Follow a pre-defined written plan Retain documented evidence of all testing and procedures

11. CBER 11 BECS End Users Validation SOPs Must be Developed 21 CFR 606.160(b)(5)(i): Records shall be maintained for calibration and standardization 21 CFR 606.100(b)(15): Equipment maintenance and calibration schedules and procedures

12. CBER 12 User Site Validation Should: * Use actual hardware and software that will be part of the installed system Be performed within the context in which the software is intended to be used Take into account any site specific issues * General Principles of Software Validation; Final Guidance for Industry and FDA Staff (1/11/2002)

13. CBER 13 User Site Validation Should: * (cont.) Ensure all system components are exercised and are the specified versions Be done throughout the full range of operating conditions Be carried out for sufficient time so the system encounters a wide range of conditions

14. CBER 14 User Site Validation Should: * (cont.) Encompass: − High volumes of data − Heavy loads or stresses − Security − Error messages − Faults − etc.

15. CBER 15 Reporting of BECS Implementation to FDA BECS:Annual Report - 21 CFR 601.12 CASI:Discussed in CASI presentation

16. CBER 16 CBER 510(k) Cleared BECS Website List http://www.fda.gov/BiologicsBloodVaccines/Bl oodBloodProducts/ApprovedProducts/Substan tiallyEquivalent510kDeviceInformation/ucm134 987.htm

17. CBER 17 CBER 510(k) Cleared BECS Website List (cont.) List of BECS is only for versions cleared by FDA List does not include versions that did not require a new 510(k) submission − Not all software changes require a new 510(k) List is not updated if a manufacturer discontinues distribution and support

18. CBER 18 References: General FD&C ACT: http://www.fda.gov/RegulatoryInformation/Le gislation/FederalFoodDrugandCosmeticActFD CAct/default.htm http://www.fda.gov/RegulatoryInformation/Le gislation/FederalFoodDrugandCosmeticActFD CAct/default.htm CFR on-line access - 1996 to 2009: http://www.access.gpo.gov/nara/cfr/cfr-table- search.html#page1http://www.access.gpo.gov/nara/cfr/cfr-table- search.html#page1

19. CBER 19 References: Reporting BECS Implementation to FDA 21 CFR 601.12: Changes to an approved application Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (8/07/2001)

20. CBER 20 References: User Site Validation General Principles of Software Validation; Final Guidance for Industry and FDA Staff (1/11/2002) Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility (10/26/2007) − Draft guidance comments to the docket are under review ­ Guidance Link: FDA website A to Z Subject Index - G Page; Click Guidance Documents – Biologics ­ http://www.fda.gov/SiteIndex/ucm148505.htm http://www.fda.gov/SiteIndex/ucm148505.htm