The Surgeon's Guide to FDA

Ten ways to use the agency's resources to advance device innovation.

Surgeons influence device safety, evidence, and policy more than most realize. This guide identifies ten practical ways to participate, from evaluating a device before adoption to generating evidence and serving in formal advisory roles.

Learn

1. Know what's regulated….and what isn't. Simulation platforms, skills-assessment AI, coaching apps, decision support — some are regulated devices, some sit under enforcement discretion, some aren't devices at all. The 2026 updates provided clarification and the Navigator walks you through the determination. Even where enforcement discretion is the current posture, know which bucket you're in.

2. Read the device file. Every cleared or approved device has a public record — bench testing, clinical data, and the reasoning behind the decision. Most of it never appears in the published literature.

3. Search MAUDE before you adopt. The public adverse event database shows real-world failure modes and use errors before you commit your program to a platform.

4. Let the agency brief you — and ask it back. Safety communications, new guidances, and meeting announcements delivered the day they publish — and a door that swings both ways: FDA answers questions from clinicians, not just companies.

Contribute

5. Write a MedWatch report that teaches. Voluntary reporting is open to you personally. One clear narrative from a surgeon who understands the anatomy carries more signal than dozens of auto-generated reports.

6. Comment on public dockets. Draft guidances and requests for information are open for public comment — and comments are read, summarized, and answered in the final document. This is where evidence expectations for your specialty get written.

7. Attend an advisory committee meeting. Panel meetings are public and webcast, and the Open Public Hearing gives any clinician the microphone.

Shape

8. Turn practice into evidence. FDA regulates devices, not surgeons — off-label use is the practice of medicine. But off-label experience only counts if it's captured.

9. Serve on an advisory panel. Panel members are practicing clinicians appointed as Special Government Employees. Self-nomination is allowed — your specialty is only represented if someone from it applies.

10. Bring your judgment inside. CDRH hires surgeons as medical officers — full-time, part-time, and fellowship routes exist, and the Center is hiring now.

Want everything? FDA's full device database index is here: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

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  ·  Research Professor of Surgical Sciences WMED

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, considering this device, these claims, these users, these risks, and this clinical setting.

For genuinely new technologies, that distinction matters.

The problem was that no one in the room could see the whole picture.

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

In twenty-five years at FDA, I reviewed surgical device submissions from some of the most sophisticated companies in the world. Companies with deep regulatory teams, experienced clinical investigators, and genuine scientific innovation behind their technology.

The submissions that failed were the ones where something wasn't aligned. The clinical evidence told one story. The intended claims told another. The proposed labeling reflected how the device performed in a controlled study setting, not how it would actually be used in a community hospital on a Tuesday afternoon. The regulatory pathway assumed a level of clinical consensus that didn't yet exist in the real world.

Individually, each piece looked reasonable. Together, they didn't hold.

What made these situations particularly difficult was the denial phase. Someone in the organization usually sensed the problem. A VP of Regulatory Affairs who couldn't quite articulate why the FDA feedback felt off. A clinical lead who privately worried the study population didn't reflect real surgical practice. A CEO who had been told everything was on track and had no reason to question it.

But sensing a problem and being able to name it clearly enough to interrupt a program that has momentum, budget, and internal champions are two entirely different things. Most organizations don't have someone in the room with the independence, the authority, and the specific pattern recognition to say: this isn't going to hold together the way you think it is. And even when they do, that person often can't get the room to move until the consequences are already arriving.

By the time a company came to FDA with a submission that had this kind of misalignment embedded in it, the path to resolution was almost always longer and more expensive than it needed to be. Not because FDA was unpredictable. But because the earlier decision points had already passed.

I left FDA to work on the other side of that dynamic. The situations I find most useful to engage with are the ones where someone already suspects something isn't right, where the program is at a consequential decision point, or where a company needs a view from outside the room that isn't attached to any internal narrative about how things are supposed to go.