There is no playbook for novel surgical devices.

Novel surgical technologies often do not fit conventional regulatory assumptions.

Clarity Surgical Advisors advises companies navigating FDA strategy when the path is not yet clear.

25 years at FDA Office Director, Surgical and Infection Control Devices - Robotic Surgery - Breast Implants - Minimally Invasive Surgery - Plastic and Reconstructive Surgery - Aesthetic Devices - AI-enabled Technologies - Board-Certified General Surgeon

Situations where this matters

Your device doesn’t fit cleanly into an existing predicate and the submission strategy reflects that uncertainty.

You’re designing a clinical trial and need to know what FDA will actually require and not only what was accepted before.

Your labeling, indications, or risk mitigations need to hold up under scrutiny you haven’t fully mapped.

FDA has asked questions your team didn’t anticipate, and the path forward isn’t clear.

A postmarket safety signal has emerged and you need to understand how FDA is likely to interpret it.

You’re preparing for an advisory committee and want to understand the room before you’re in it.

You are evaluating a surgical device company and need independent read on whether the regulatory pathway is realistic.