KBC Prompts eSTAR Changes

You may have noticed that the FDA introduced some changes in their eSTAR ‘Device Specific EMC Considerations’ as follows:

• Text changed from ‘select the most severe risk’ to ‘select the most severe harm’
• Clarification that this question pertains to potential harm from the subject device only, and therefore the context of this question does not include harm that may be caused by any other nearby medical device
• Clarification that the most severe harm should be assessed before mitigation measures, not after

Why the change? It's because of KBC! Through direct exchanges with the FDA, we sought clarification regarding eSTAR device considerations. The FDA eSTAR team appreciated our input, saying: "We consulted internally about this and will be making changes in the next eSTAR update as a result.  Thank you for your feedback, let us know if you find anything else."

We were glad to help prompt improvements to this important eSTAR section! This update is one example of how KBC is at the forefront of FDA regulatory knowledge and practice, even influencing FDA expectations applying to all 510(k) medical device applications. If your company could benefit from our expertise, please reach out to us at info@kenblockconsulting.com.

New eSTAR Wording

The updated eSTAR section is shown below:

Importance & Impact of the Changes

RISK VS. HARM: The text change from 'risk' to 'harm' alters how Sponsors should interpret the FDA guidelines. Risk is the combination of severity of harm and probability of occurrence of that harm. By changing the focus to harm only, eSTAR Sponsors should not factor in the probability of occurance of harm to their considerations in answering this question, thereby potentially affecting how safe FDA considers the subject device to be while reviewing the submission.

SUBJECT DEVICE ONLY: By clarifying that the context of harm is limited to the subject device only, manufacturers should be able to answer this question more easily and accurately. If the context of harm extended to any medical device in the vicinity of the subject device, this question would be very difficult and time-consuming to answer since a manufacturer would not be familiar with the specific harms of other devices, and every known medical device would need to be considered.

PRE-MITIGATION VS. POST-MITIGATION: By clarifying that the severity of harm needs to be assessed prior to mitigation and control, this could potentially affect how safe FDA considers the subject device to be while reviewing the submission. This consideration will ultimately result in safer devices and experiences for the patient, user, or operator.