Impact of the New FDA Guidance (July 2024)

FDA Draft Guidance: Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products

by Conni Kratzer

On July 8, 2024, the FDA released a new draft guidance document that has the potential to enhance the effectiveness and efficiency of human factors (HF) programs for drug delivery devices.

In this blog post, we’ll delve into key elements of this new draft guidance and illustrate how a thorough Use-Related Risk Analysis (URRA) can tailor your HF activities and help you navigate the FDA approval process more efficiently. In some cases, it can even serve as a basis for bypassing the need to submit HF validation data, thereby expediting product launch.

Understanding URRAs

A URRA is a risk analysis tool used to identify use-related risks associated with a product and to determine measures to reduce these risks. Manufacturers of drug delivery devices should initiate the URRA early during product development and update it throughout the product lifecycle as part of a broader risk management program based on International Organization for Standardization (ISO) 14971 Application of risk management to medical devices (2019) (ISO 14971). While a URRA can be created as a stand-alone document, it can also be derived from an existing use failure mode and effects analysis (uFMEA).

Creating a Complete URRA

When developing a comprehensive URRA, you should take all potential uses, users, and use environments of a product into consideration. These factors may impact design, user tasks, risks, and harms, so it is important to take them into account in the following seven steps for creating a complete URRA. These steps are outlined in the draft guidance, which also includes an example of an abbreviated URRA in table format:

 1.     Identify User Tasks: Document all user tasks, including both physical interactions and knowledge-based tasks, such as interpreting labeling information. Use methods such as task analysis or contextual inquiry to ensure a thorough understanding of user-device interactions.

2.     Identify Potential Use Errors: Determine potential use errors that are reasonably expected to occur. Utilize tools such as literature reviews, adverse event reports, and experience with similar products.

3.     Identify Potential Harms: Assess each identified use error for potential harms and their severity. Consider factors such as the frequency and urgency of product use and differentiate between singular and repeated errors.

4.     Categorize Tasks: Classify tasks as critical or non-critical. Critical tasks are user tasks which, if performed incorrectly or not performed at all, would or could cause harm to the patient or user, where harm is defined to include compromised medical care.

5.     Identify Risk Controls: Implement risk controls to mitigate identified risks, following the priority order from ISO 14971:

1)    inherently safe design and manufacture;

2)    protective measures in the product itself; and

3)    information for safety (such as labeling) and training.

6.     Identify Evaluation Methods: Specify the methods used to evaluate the effectiveness of risk controls, such as HF validation testing.

7.     Update the URRA: Regularly update the URRA throughout the product lifecycle to reflect any changes to the user interface or new risk information.

Tailoring your HF activities

The new draft guidance not only explains how to develop a comprehensive URRA but also outlines how it can be used to tailor your HF activities. A URRA can aid in creating a precise HF validation study protocol by identifying the user tasks and risk controls that need to be evaluated to support a successful marketing application. While HF validation testing remains a crucial part in the development of many drug delivery devices, the draft guidance acknowledges situations where such testing may not be necessary if you present a strong, detailed justification.

If products that are similar to the proposed drug delivery device exist, you can conduct comparative analyses, i.e., labeling, task, and physical comparison, to assess whether differences between the proposed product and existing comparators exist. Using the URRA, you can then determine if the same or similar risks apply to both products. Based on this analysis, you can build a justification whether HF validation data is needed to support the marketing application. In addition to the URRA and comparative analyses, this justification should consider other key factors such as user characteristics, user experience and familiarity with the product, dosing, use scenarios, and use environments. The draft guidance outlines the path to submit a justification, along with supporting information like the URRA and comparative analyses, to the FDA to forego the need to submit HF validation data.

Given that HF validation is time-consuming and time to market is increasingly critical, implementing this draft guidance could save time and money, expedite FDA review timelines, and bring products to market faster, ultimately benefiting patients.

Adopting the New FDA Draft Guidance

A well-crafted URRA can substantially improve the effectiveness and efficiency of your HF program, saving time and resources by optimizing your overall approach and streamlining the regulatory review process. At Design Science, we are your human factors partner, leveraging our expertise to drive upfront documentation and craft a compelling URRA that aligns with FDA expectations.

If you are looking to create a comprehensive and successful URRA that will direct and scale your HF program, including your validation activities, reach out to Design Science for expert support.

We can help you achieve smooth FDA approval by:

• Creating a comprehensive URRA or updating your current risk analysis to meet FDA expectations.

• Developing a precise and complete validation protocol based on the URRA.

• Crafting a compelling rationale that justifies why HF validation study results may not be required.

For more insights on the new URRA draft guidance, uFMEAs, and compelling technical arguments, tune in to the Combinate Podcast featuring our Research Director Dr. David Grosse-Wentrup.

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