A client had an ophthalmology software as a medical device. An unforeseen event caused their previous regulatory consultant to retire and become completely unavailable amid the 510(k) review. The history of the FDA interactions previously was incomplete.

The original 510(k) and the FDA’s request for information were missing a significant amount of information, including an inadequate device description and missing software details. The predicate strategy was also faulty and raised into question whether the product was able to receive a 510(k), which the client needed to form partnerships and maintain a viable business.

After the FDA request for information was received, the consultant provided little guidance on the response, resulting in a draft that was insufficient for addressing the FDA concerns, including the resolution of the predicate strategy.

No Submission Issue Request (SIR) had been submitted to resolve this issue integral to the submission.

The client discussed its needs, expectations, and regulatory history with our team. After regulatory team members reviewed the prior submissions and regulatory landscape, we followed up with additional questions to help navigate the appropriate approach to FDA's requests. Throughout the process, the client maintained a high level of involvement, so we engaged with them through numerous meetings during the preparation of the response to ensure they understood our recommendations.

Because the original submission was lacking the appropriate detail necessary for a thorough FDA review, we fully examined the product and rewrote in-depth device description documents to realign with FDA on the principles of operation of the new device.

After working on the predicate strategy and new device description, due to the unique nature of the regulatory landscape around this device, we felt it was necessary to speak with FDA on the strategy before submitting the response to ensure the success of the submission. We crafted the argument for inclusion in a Submission Issue Request and held the meeting in which we received confirmation on our approach and greater insight into the review team's thinking about the device.

A suitable predicate strategy was ultimately identified, and the submission and response were cleaned up.

“This case study is a good example of how we approach all of our clients,” says Isabella Schmitt, Director of RA/Q. “We aim to understand their needs and resolve important issues, even when the difficulty arose elsewhere, and all information is not what we hoped it would be. We can react and adjust quickly because our team has vast knowledge in regulatory affairs across multiple indications as well as a background in biomedical engineering, electrical engineering, software, chemistry, biology, risk assessments, clinical design, and quality assurance. We all have years of experience specifically serving innovative companies and frequently changing projects.”

Upon submission of the request for information response, FDA cleared the product with its newly identified predicate.

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