Drugdu.com expert's response:

The U.S. Food and Drug Administration (FDA) has clear regulatory requirements for the usability engineering of medical devices, primarily outlined in the "21 CFR 820" (Design Controls) and related guidance documents issued by the FDA. Below is a detailed summary of the FDA's regulatory requirements for medical device usability engineering:

I. Design Control Requirements

According to "21 CFR 820.30," the FDA requires medical device manufacturers to take appropriate measures during the design and development process to ensure that products meet safety and effectiveness requirements. These measures include, but are not limited to:

Consideration of User Needs: The design team must thoroughly consider the end-users of the device, including healthcare professionals, patients, and the operating environment, to ensure that the product meets their usage needs and expectations.

Risk Management: Designs must assess and mitigate potential use error risks, which is closely related to ISO 14971 (Risk Management for Medical Devices). Especially when designing user interactions, possible use errors should be predicted and analyzed, with corresponding design controls implemented to reduce these risks.

Verification and Validation: Design verification (to confirm that the product meets user needs and specified standards) and design validation (to ensure that the product design is suitable for its intended use) are required. This includes conducting user testing on the product to verify its ability to effectively prevent use errors and ensure safe user operation.

II. Related Guidance Documents

The FDA has issued multiple guidance documents on medical device usability engineering, with "Human Factors and Usability Engineering for Medical Devices" being the most significant. These documents provide specific guidelines for medical device usability engineering, particularly on how to assess and reduce use-related risks. The document details the usability engineering process for medical devices, including how to identify and mitigate risks that may arise from user errors during the design phase. It emphasizes that the design of medical devices should not only meet functional requirements but also ensure that the device is easy to use, avoids misoperations, and minimizes risks due to improper use.

III. Usability Engineering Documents Submitted to the FDA

For most Class II and Class III medical devices, the FDA requires manufacturers to submit related usability engineering documents. These documents typically include:

Detailed Usability Testing Results: Documentation of the user testing process, results, and any design improvements implemented.

Risk Assessments: Including identified use errors, potential risks, and control measures implemented.

User Task Analysis: Manufacturers must conduct design task analyses to ensure that device designs meet user needs and reduce operational errors.

IV. Other Requirements

Clinical Testing and User Feedback: The FDA encourages manufacturers to conduct pre-clinical user testing and collect user feedback after product launch to assess the device's usability in real-world environments. When necessary, the FDA may require manufacturers to submit revised designs to address post-market feedback issues.

Management of Operational Errors: The FDA emphasizes that all design decisions should focus on reducing operational errors, especially in medical devices that may have significant impacts on patient health.

In summary, the FDA's regulatory requirements for medical device usability engineering encompass design controls, adherence to related guidance documents, submission of necessary usability engineering documents, and other specific requirements. Manufacturers need to strictly comply with these requirements to ensure that their products are both safe and efficient in actual use, reducing user errors, and enhancing patient safety.