REGULATORY UPDATE: FDA Issues New Guidance Related to Device Software Functions

The Food and Drug Administration issued a new final guidance this month, “Content of Premarket Submissions for Device Software Functions,” that details the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which includes devices used by the blood and biotherapies community.

In the guidance, FDA states its intention to take a risk-based approach to help determine the device’s documentation level, which is either basic or enhanced, based on the risks of its device software function(s) in the context of the device’s intended use.

The agency specifies that enhanced documentation “should be provided for any premarket submission that includes device software function(s) where a failure or flaw of any device software function(s) could present a hazardous situation with a probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use.”

Basic documentation should be provided for any premarket submission that includes device software function(s) where enhanced documentation does not apply.

The agency recommends enhanced documentation for devices intended to test blood donations for transfusion-transmitted infections, devices used to determine blood donor and recipient compatibility, automated blood cell separator devices intended for collection of blood and blood components for transfusion or further manufacturing use, and blood establishment computer software (BECS).

In addition, the guidance contains an appendix of examples to demonstrate the implementation of the documentation level risk-based approach for these devices. FDA notes that these generalized examples do not necessarily account for every possible detail, risk or consideration a sponsor should evaluate, and should not be taken to mean that the devices described do or do not require a certain documentation level.

Individuals with questions may contact AABB Regulatory Affairs.