The FDA to discuss classification of Blood Establishment Computer Software

Extract from ‘FDA Executive Summary: Classification of Blood Establishment Computer Software (BECS) and BECS Accessories. Prepared for the December 3, 2014 Device Classification Panel Meeting of the Blood Products Advisory Committee (BPAC)’

BECS and BECS accessories are devices used in the manufacture of blood and blood components to assist in the prevention of disease in humans by:

  • identifying unsuitable donors;
  • preventing the release of unsuitable blood and blood components for transfusion or for further manufacturing into products for human treatment or diagnosis;
  • performing compatibility testing between the donor and recipient; and/or
  • performing positive identification of patient and blood component.

The Food and Drug Administration (FDA) is convening the Blood Products Advisory Committee (BPAC) as a Device Classification Panel (the Panel) to discuss classification of blood establishment computer software (BECS) and BECS accessories.

The Panel will be asked to provide recommendations on the classification of BECS and BECS accessories as Class I, II or III medical devices based on the level of control necessary to provide a reasonable assurance of their safety and effectiveness.

If the Panel recommends Class II classification for BECS and BECS accessories, the Panel will also be asked to discuss special controls that would be sufficient to provide reasonable assurances of their safety and effectiveness. Special controls are regulatory requirements for class II devices. They are usually device specific and may include performance standards, postmarket surveillance, special labeling requirements, premarket data requirements, or other controls.

The Panel will be asked to recommend a classification for BECS and BECS accessories, after which FDA will propose a regulation that identifies and classifies this generic device type. Once finalized, this regulation will be published in the CFR.

FDA Recommendation 

FDA believes that special controls, in addition to general controls, should be established to mitigate the risks to health identified below and provide a reasonable assurance of the safety and effectiveness of BECS and BECS accessories.

Based on the safety and effectiveness information, and the identified benefits and risks, FDA recommends the classification of BECS and BECS accessories as Class II devices subject to special controls. The following regulatory language is proposed:

864.XXXX Blood establishment computer software and BECS accessories

(a) Identification. Blood establishment computer software (BECS) and BECS accessories are devices used in the manufacture of blood and blood components to assist in the prevention of disease in humans by identifying unsuitable donors, preventing the release of unsuitable blood and blood components for transfusion or for further manufacturing into products for human treatment or diagnosis, performing compatibility testing between donor and recipient and performing positive identification of patients and blood components. A BECS accessory expands or modifies the function of the BECS and/or indications for use of the BECS device. These devices are intended for use with or capable of functioning with BECS for the purpose of augmenting or supplementing the BECS performance.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Software performance and functional requirements are provided in the premarket submission including detailed design specifications, e.g., algorithms or control characteristics, alarms, device limitations, and safety requirements.

(2) Verification and validation testing and hazard analysis are performed and provided in the premarket submission.

(3) Labeling includes:

  • (i) Software limitations;
  • (ii) Unresolved anomalies, annotated with an explanation of the impact on safety or effectiveness;
  • (iii) Revision history; and,
  • (iv) Hardware and peripheral specifications.

(4) Traceability matrix is performed and submitted in the premarket submission.
(5) Performance testing is performed and provided in the premarket submission, as necessary, to ensure the safety and effectiveness of the system, and when adding new functional requirements, (e.g., electrical safety, electromagnetic compatibility, or wireless coexistence).

See details in:(http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics/bloodproductsadvisorycommittee/ucm424983.pdf)