Discover how medical device companies used FDA Pre-Submissions to clarify regulatory pathways, refine testing strategies, avoid costly missteps, and secure smoother, faster approvals through early collaboration and actionable feedback.
To illustrate the impact of the Pre-Submission process, let’s explore a couple of real-world examples (generalized from actual scenarios) where early FDA engagement made a significant difference:
A small startup was developing an AI-driven imaging software for a new diagnostic application. It was unclear whether their product would be regulated as a Class II device via 510(k) or would require the De Novo pathway (no clear predicate existed). The team decided to submit a Pre-Submission with two main questions: (1) Is our device appropriately classified under the existing regulation/product code we identified? (2) Does our proposed validation testing plan (bench and reader studies) adequately address the novel aspects of the device? They provided a device description, a preliminary comparison to what they thought was the closest predicate, and outlined their testing strategy.
About 70 days later, FDA’s written response arrived. For the classification question, FDA agreed with the team’s suggested classification/product code – confirming that a 510(k) would be the right pathway. This was a huge relief, as it meant they likely did not need to pursue a De Novo. On the second question, FDA did not fully agree that the validation plan was sufficient. The feedback contained several specific suggestions to improve the performance comparison and testing plans. For instance, FDA recommended additional stress testing for the software algorithm and a broader dataset for the reader study to prove accuracy across different conditions.
The company had a teleconference with FDA (one hour) to discuss these points. During the meeting, the team focused on clarifying FDA’s suggestions for the testing plan. They asked questions like “If we add X analysis and include Y scenarios in the testing, would that resolve your concern?” FDA provided clarification that helped the company fully understand how to modify their protocols. The team did not waste time re-presenting basic information – they went straight into Q&A on the feedback, ensuring every FDA concern was addressed. By the end of the meeting, both sides had a clear understanding of what the company would do next. The startup promptly drafted the meeting minutes and sent them to FDA, who concurred with the summary.
Armed with this feedback, the company adjusted their plans: they expanded their validation study and performed the extra tests FDA recommended. When they eventually submitted the 510(k), it sailed through the FDA review with no major surprises – the FDA had essentially pre-vetted the critical aspects. The classification was agreed, and the testing met expectations. The device gained clearance on the first pass. Company leadership noted that without the Pre-Sub, they might have under-scoped their testing and faced an FDA request for additional information, delaying market entry. Instead, early engagement avoided delays and built FDA’s confidence in the submission.
A mid-sized manufacturer had a novel therapeutic device that they assumed would be a Class II device with a 510(k). They prepared a Pre-Submission to discuss their plan and ask if any clinical data would be needed or if bench testing was enough. In their Pre-Sub package, they described the device, proposed a predicate, and listed planned bench tests. One key question was, “Does FDA agree that no human clinical study is required given the existing data on similar devices?”
FDA’s response in writing was a bit of a wake-up call. They agreed the device was likely Class II, but pointed out that no appropriate predicate had been identified – meaning the device might not be eligible for 510(k) at all. FDA suggested the company consider the De Novo pathway due to novel features. Additionally, FDA recommended a small clinical study to demonstrate effectiveness for a specific novel claim the company was making, contrary to the company’s assumption that bench data would suffice.
Thanks to this early feedback, the company pivoted its regulatory strategy months before filing anything. They opted to pursue a De Novo request instead of trying a 510(k) that would likely fail. They also designed a modest 30-patient clinical trial to gather the necessary data, as FDA had hinted. This change undoubtedly saved them from an inevitable Not Substantially Equivalent (NSE) letter had they tried the 510(k) route without a predicate. While a clinical study added time, doing it upfront was far better than being told to do it after a failed submission.
When they eventually submitted the De Novo, the application was solid and aligned with FDA’s expectations (the Pre-Sub feedback was referenced throughout). FDA reviewers, already familiar with the device from the Pre-Sub, processed the application efficiently. The De Novo was granted with the first cycle review. Company executives later reflected that the Pre-Submission likely saved a year or more of back-and-forth that would have occurred if they had attempted the wrong pathway initially.
A small startup was developing an AI-driven imaging software for a new diagnostic application. It was unclear whether their product would be regulated as a Class II device via 510(k) or would require the De Novo pathway (no clear predicate existed). The team decided to submit a Pre-Submission with two main questions: (1) Is our device appropriately classified under the existing regulation/product code we identified? (2) Does our proposed validation testing plan (bench and reader studies) adequately address the novel aspects of the device? They provided a device description, a preliminary comparison to what they thought was the closest predicate, and outlined their testing strategy.
These case studies highlight a few takeaways: – Pre-Subs can confirm your regulatory pathway and prevent false starts. – They can reveal hidden requirements (like a needed clinical test or different predicate) while you still have time to act. – Feedback from Pre-Subs, when incorporated, leads to smoother submissions with fewer deficiencies. – Even negative results (learning your assumptions were wrong) are extremely valuable early on – far better than learning them mid-review or post-submission.
Real companies large and small have successfully used the Pre-Submission program to de-risk their projects. By engaging FDA early, they turn what could be a one-sided review process into a collaborative dialogue, ultimately benefiting their timeline and the safety/effectiveness of the device. In the final section, we’ll discuss how to follow up after a Pre-Sub and translate the FDA feedback into action items that propel your project forward.
