Your Regulatory Team is Doing Everything Right. That May Be the Problem.

Binita S. Ashar, MD, MBA, FACS, MAMSE  ·  Founder, Clarity Surgical Advisors  ·  Former FDA Office Director

The most experienced regulatory teams know how to read precedent. They know which predicates were accepted, how FDA has historically evaluated similar technologies, and which arguments have worked before.

That expertise matters. But in surgical robotics, aesthetic and reconstructive devices, and other technologies where performance depends on workflow, user technique, software, or complex clinical context, precedent is only a starting point.

These products don't fit neatly into what came before. The comparator may be imperfect. The endpoint may not capture what actually matters in use. The failure modes may not resemble those of prior devices in the category. And the regulatory questions may have less to do with what FDA accepted before than what this specific technology will do in actual clinical practice.

Over twenty-five years at FDA, I saw sophisticated companies make the same mistake:

They mistook regulatory precedent for how FDA will evaluate risk, use, and evidence for their device.

That is where otherwise strong programs begin to drift. It shows up as questions the team did not anticipate, requests for data that do not seem to follow precedent, or late recognition that the evidentiary story and the clinical reality were never fully aligned.

The companies that navigate this well are not simply the ones with deep knowledge of prior submissions. They are the ones that can assess the product the way FDA will: this device, these claims, these users, these risks, and this clinical setting.

For genuinely new technologies, that distinction matters.