Following up on work initiated in 1998, the US Food and Drug Administration (FDA) issued a proposed rule to categorize blood establishment computer software (BECS) and accessories into class II.
More than 220 BECS and accessories have received FDA clearance and these all currently fall into class III—reserved for those medical devices that pose a higher risk of patient illness or injuries, such as pacemakers and heart valves.
FDA’s decision is based on the recommendations received from a panel—the Blood and Product Advisory Committee—initially convened in 1998, and again in December 2014, after the first BECS 510(k) submission was cleared in August 1996 with comparisons made to pre-amendment devices.
The panel recommended regulating BECS as a class II device with premarket review. Yet the classification was not finalized in 1998 “because of competing priorities,” FDA said.
As defined in FDA guidance
issued in 11 May 2005, a BECS is a software product “intended for use in the manufacture of blood and blood components or for the maintenance of data that blood establishment personnel use in making decisions regarding the suitability of donors and the release of blood or blood components for transfusion or further manufacture.”
The guidance set forth policies on premarket submission content for software contained in medical devices. It characterized BECS as a software product with “major level of concern,” as this device type and its accessories may present several risks to health, including an adverse reaction or death resulting from an unintentional release of incompatible blood or blood components.
However, FDA says these potential risks can be mitigated by the special controls detailed in the proposed rule, such as the inclusion of a hazard analysis and traceability matrix for the software.
The decision to ease regulatory controls over this type of device and its accessories coincides with other efforts in recent years to spur innovation for software as a medical device (SaMD).
Another example of how the agency intends to incentivize more software developers to innovate and bring their products to the US market relates to the Center for Devices and Radiological Health’s pre-certification program through which participants intend to create a new regulatory paradigm using the risk-based approach on SaMD developed via the International Medical Device Regulators Forum.
Under section 510(m) of the Food, Drug and Cosmetic Act
, a class II device can be exempt from premarket notification if it is believed special controls are sufficient to provide reasonable assurance of safety and effectiveness.
But FDA has also determined premarket notification should remain a requirement for a BESC clearance, thus it does not intend to provide an exemption from 510(k) requirements on this type of devices.
Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories