1	Medical Devices involved in Blood Donor Collection, Processing and Screening and HIV Diagnosis Diane M. Gubernot, M.P.H. Senior Scientific Reviewer Division of Emerging and Transfusion Transmitted Diseases OBRR/CBER
2	Objectives of this presentation: To describe the devices reviewed at CBER To define accessories to these devices To summarize regulations and guidance documents applicable to software systems for premarket applications
3	Devices Reviewed at CBER: Medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products. CBER also regulates all retrovirus (e.g., HIV) test kits to diagnose, treat and monitor persons with HIV and AIDS.
4	Blood Bank & HIV Diagnostic Instrument/Software Devices may be: Stand-alone software - requires no other devices to effect its intended use. Primarily Blood Establishment Computer Software (BECS) Software that is used in conjunction with automated instruments Automated & semi-automated instruments containing firmware (embedded software) Accessories (e.g. barcode scanners, interfaces) that are used with of any of the above devices Accessory software is linked to a device/instrument and can be either required or optional.
5	Medical Device Accessories An accessory to a device is, by definition, a device itself. Software that interfaces to a device or devices is an accessory to that device or devices; however, whether or not it needs a regulatory submission depends on its intended use.
6	When is Software an Accessory to a Device? Is the data transfer bi-directional (two-way)? Is the data transfer uni-directional (one way)? If so, are the data used clinically? Are the data needed for the safe use of the instrument? Are the data necessary for the proper operation of the instrument? If yes, to any of the above, it is most likely an accessory.
7	When is a Regulatory Submission Needed? The determination of whether or not a regulatory submission is needed is based on the intended use of the accessory Medical vs. non-medical information One way vs. two way data flow
8	How Do I Know What Kind of Regulatory Submission is Required? The accessory is regulated like the parent device. If the interface is between devices that have different regulatory submission requirements, the accessory is regulated like the parent device with the more stringent submission requirements.
9	Examples of Accessories That Require a Regulatory Submission: A “Data Management System” that processes or stores data that is used clinically An order entry or results return interface from or to a device that requires a regulatory submission
10	Accessories That Require a Regulatory Submission: A software interface marketed as an option to link an HIV diagnostic system with a Laboratory Information System. Accessory to a Class III device.
11	What Are Transfusion Safety Management Systems? An electronic system consisting of a barcode scanning device, specialized software, a portable printer (sometimes), and possibly other accessories Intended specifically for use in matching blood components to the intended recipient Used to scan the barcode on the blood product and the barcode on the patient arm band at the time of transfusion
12	Transfusion Safety Management Systems Although these systems might be considered to be an accessory to a device, transfusion safety management systems have been determined to be medical devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (Act)[21 U.S.C. 321(h)] and require a 510(k) submission.
13	Platforms used for Donor Screening Assays Intended Use: For donor blood screening Indications for Use: The analyte or specific assay for which you are seeking clearance/approval Note: A change in intended use or indication for use precludes submission of a Special 510(k)
14	When Submitting Software/Instrument Applications to CBER: Manufacturers should follow Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - 5/11/2005 (available at www.fda.gov/cdrh/ode/337.html).
15	Medical Devices involved in Donor Blood Screening or HIV Diagnosis: FDA has determined these to be a Major Level of Concern devices. Announced and discussed at BPAC on June 15, 2002
16	CBER’s Current Considerations: Donor Screening devices for infectious disease testing are: High-risk products Integral to the assay system Require data for safety and effectiveness Highly automated with little or no user intervention Perform Package Insert activities, e.g. control parameters and algorithms for result interpretation Major Level of Concern
17	CBER’s Current Considerations: Submission Options: Include the platform documentation in the BLA Submit a separate PMA for the platform Consistent with CDRH’s regulatory review process (intended use of the assay) Risk-based decision
18	Summary: All software/instrument systems must follow the QSR for system development. General Principles of Validation Guidance document should also be referenced. Donor screening devices → Major Level of Concern Accessories to medical devices are classified the same as the parent device. The Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices should be followed to expedite the review process.
19	CBER Contacts: Seek guidance from CBER prior to submitting an application. ABO/Rh devices and BECS: DBA: Linda Weir 301-827-6136 Blood collection/infectious disease test devices: Regulatory Products Management Branch 301-827-3524