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

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

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

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

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

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

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

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

CBER 9 BECS End Users User Site Validation Overview Done outside developer’s controlled environment − 21 CFR (Blood Establishments Only) − 21 CFR (b)(5)(i) − 21 CFR (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

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

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

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)

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

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

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

CBER 16 CBER 510(k) Cleared BECS Website List oodBloodProducts/ApprovedProducts/Substan tiallyEquivalent510kDeviceInformation/ucm htm

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

CBER 18 References: General FD&C ACT: gislation/FederalFoodDrugandCosmeticActFD CAct/default.htm gislation/FederalFoodDrugandCosmeticActFD CAct/default.htm CFR on-line access to 2009: search.html#page1http:// search.html#page1

CBER 19 References: Reporting BECS Implementation to FDA 21 CFR : 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)

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 ­