FDA issues draft revised guidance on usability studies

The US Food and Drug Administration (FDA) has issued a draft guidance document titled ‘Content of Human Factors Information in Medical Device Marketing Submissions: Draft Guidance for Industry and Food and Drug Administration Staff“ The draft is intended to be, when finalised, a companion guidance to document ‘Applying Human Factors and Usability Engineering to Medical Devices‘, dated February 2016, replacing draft guidance ‘List of Highest Priority Devices for Human Factors Review‘, also dated February 2016. The Agency explains that “The purpose of the current guidance is to help manufacturers apply a risk-based approach when considering what human factors information to include in a marketing submission.”

The new draft includes a flowchart and associated explanations to help submitters identify the appropriate ‘Human Factors (HF) Submission Category’. The result will identify what level of usability information should be included in the submission, viz:

• HF Submission Category 1. Provide conclusion and high-level summary of HF evaluation.
• HF Submission Category 2. Provide rationale in submission for why: there are no critical tasks (new devices only); or there are no new critical tasks introduced and/or no changes that impact critical tasks (modified devices only).
• HF Submission Category 3. Provide a human factors engineering report that includes validation testing addressing: critical task(s) (new devices only); or new critical task(s) introduced or existing critical task(s) impacted by change (modified devices only.

The draft also includes comprehensive details of the HF documentation needed in case of a modified device.

Comments are invited until 9 March 2023.