SENIOR REGULATORY ADVISORY FOR SURGICAL DEVICES
There is no playbook for novel surgical devices.
I spent from 2000 to 2025 at FDA, most recently leading the office responsible for surgical and infection-control devices. I now advise companies navigating consequential regulatory, evidence, and product-risk decisions.
Binita S. Ashar, MD, MBA, FACS, MAMSE
Former Office Director, Surgical & Infection Control Devices
U.S. Food and Drug Administration
Regulatory judgment grounded in surgery
I trained and practiced as a general surgeon, and stayed in clinical practice on a limited basis through much of my 25 years at FDA. Regulatory decisions look different when you have been in the operating room. That shapes the judgement I bring to companies now.
What Clarity Provides
Clarity provides independent senior judgment at the moments when regulatory strategy, clinical evidence, labeling, product risk, postmarket signals, and real-world use have to hold together.
Clarity is not a submission-writing firm, CRO, or replacement for an internal regulatory team. The work is strategic. I help teams identify risk, pressure-test assumptions, prepare for FDA interactions, and understand the decision in front of them.
Where Clarity is Most Useful
No Clean Predicate
Your device doesn’t fit cleanly into an existing predicate and the submission strategy reflects that uncertainty.
A Faster Path
You are about to take the standard regulatory path and want to know whether a faster, smarter one exists for your device.
Trial Design
You’re designing a clinical trial and need to know what FDA will actually require and not only what was accepted before.
Labeling and Risk
Your labeling, indications, or risk mitigations need to hold up under scrutiny you haven’t fully mapped.
Unexpected Questions
FDA has asked questions your team didn’t anticipate, and the path forward isn’t clear.
Postmarket Signals
A postmarket safety signal has emerged and you need to understand how FDA is likely to interpret it.
AI and Automation
Your device incorporates AI or automation and you need to know how its decisions will be evidenced, and defended after deployment.
Advisory Committee
You’re preparing for an advisory committee and want to understand the room before you’re in it.
How I Work
I work with teams through focused advisory calls, on site working sessions, and preparation for FDA interactions.
My work often starts by helping a team see the decision in front of them more clearly. I review the materials they plan to put in front of FDA, including submissions, briefing documents, slide decks, and presentations. I look for regulatory and evidence opportunities they may not have recognized, especially in data they already have, FDA policy they may not have considered, or strategic options that have not yet been tested.
A large part of my work is coaching. I help teams frame the question, explain the clinical context, present the evidence, and anticipate the concerns FDA is likely to raise. The goal is not just to prepare better slides. It is to help the team walk into the FDA interaction clearer, more aligned, and better prepared.
Who Clarity Serves
Clarity is best suited for companies developing novel surgical, robotic, AI-enabled, aesthetic, reconstructive, or infection-control technologies where the regulatory path is consequential and not fully routine.