510(k) Submissions Can Be Rejected
Why do approximately 30% of medical device 510(k) submissions fail* initial review? After spending extensive time and resources on a 510(k) submission, the worst news a team can receive is that their application has failed. Application rejection is not uncommon, but the good news is there are steps you can take to prevent it.
Common causes of 510(k) rejections include unclear instructions-for-use (IFU), product design or performance issues, overlooked critical tasks and safety risks, and noncompliance with strict U.S. Food and Drug Administration (FDA) protocols. In addition, inadequate design and execution of human factors engineering (HFE) studies are a significant reason for noncompliance rejections. Addressing these issues is necessary for successful FDA submissions. Although it can be time-consuming and costly to implement solutions, it is less expensive than the cost of 510(k) application failure.
Your HFE Study Can Make or Break Your Application
HFE studies are often required by the FDA to ensure device safety, but execution of these studies is sometimes treated as a box-checking measure. Companies that underestimate the importance of HFE studies risk time-consuming, costly issues during the FDA review. Likewise, an improperly conducted HFE study can result in a company needing to devote additional time, money, and resources to rework and resubmit the application. When done well, HFE studies can identify usability issues before submission, giving companies the ability to mitigate any issues that could impact safety, thereby increasing the chances of a smooth approval process.
When HFE Studies Are Done Incorrectly
Inadequate HFE studies can fail to identify usability issues, leading to unforeseen problems and poor product design, all of which must be addressed before resubmission. Failure to identify and address poor design could lead to patient harm and poor clinician receptivity. Missing key usability information, deviating from FDA standards, or having design flaws that hinder performance are examples of pitfalls that can lead to FDA submission failure. This can directly impact project timelines, market entry, and revenue generation. Identifying and addressing design issues early helps to prevent costly, time-intensive corrections later.
HFE Done Right—Improving FDA Submission Acceptance
A well-structured, iterative HFE approach involving continuous usability feedback, early formative testing, and adherence to FDA protocols significantly reduces the risk of application failure. A robust HFE process not only supports device safety and compliance but also can enhance market acceptance and position a device for commercial success.
Partnering with qualified professionals with an extensive understanding of FDA guidelines and usability testing methods to develop and execute a compliant, thorough, and well-documented study helps keep HFE costs manageable and increases the likelihood of a successful submission.
We’re Here to Help
As a subsidiary of the Institute for Safe Medication Practices (ISMP)—an affiliate of ECRI—Med Safety Board conducts comprehensive and refined HFE studies for successful FDA submissions and in-market regulatory responses. With decades of medical device evaluation experience, an in-house team of product safety experts who are also end-user clinicians, and access to ISMP and ECRI national error reporting programs, we deliver rigorous and effective HFE studies designed to help accelerate FDA applications and improve clinician acceptance.
Learn more about how Med Safety Board can improve HFE study processes to achieve successful FDA submissions.
* 4th Quarter FY 2022 MDUFA IV Performance Report. U.S. Food and Drug Administration. November 16, 2022. Accessed November 14, 2024. www.fda.gov/media/163306/download