The Surgeon's Guide to FDA
Ten ways to use the agency's resources to advance device innovation.
I presented this list at the Society of Robotic Surgery 2026 Annual Meeting.
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.
Digital Health Policy Navigator: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-policy-navigator
Clinical Decision Support Software guidance (final, January 2026): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software
General Wellness Policy for Low Risk Devices (updated January 2026): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices
Policy for Device Software Functions and Mobile Medical Applications: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications
Good Machine Learning Practice guiding principles: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles
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.
510(k) database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
De Novo database (decision summaries): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm
PMA database (SSEDs — Summaries of Safety and Effectiveness Data): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
Product Classification (find any device type's class and regulation): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm
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.
MAUDE: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
522 Postmarket Surveillance Studies (surveillance FDA has ordered on marketed devices): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm
Post-Approval Studies database (conditions attached to PMA approvals — and their status): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm
AccessGUDID (public device identifier database): https://accessgudid.nlm.nih.gov
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.
Subscribe to CDRH email lists: https://www.fda.gov/about-fda/center-devices-and-radiological-health/subscribe-cdrh-email-lists
Safety Communications: https://www.fda.gov/medical-devices/medical-device-safety/safety-communications
Device Advice: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance
DICE (Division of Industry and Consumer Education): DICE@fda.hhs.gov
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.
MedWatch (Form 3500 online): https://www.accessdata.fda.gov/scripts/medwatch/
MedSun (FDA's sentinel clinical network): https://www.fda.gov/medical-devices/medical-device-safety/medsun-medical-product-safety-network
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.
Open FDA dockets: https://www.regulations.gov (search "FDA" + your device area)
7. Attend an advisory committee meeting. Panel meetings are public and webcast, and the Open Public Hearing gives any clinician the microphone.
Advisory committee calendar: https://www.fda.gov/advisory-committees/advisory-committee-calendar
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.
The registry model: Abdominal Core Health Quality Collaborative (formerly AHSQC): https://www.achqc.org
Surgeon-initiated IDE studies (investigational device exemptions): https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide
Document the UDI so your cases link to the exact device used.
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.
Advisory committee membership and nominations: https://www.fda.gov/advisory-committees/advisory-committee-membership
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.
CDRH careers: https://www.fda.gov/about-fda/center-devices-and-radiological-health/cdrh-jobs
Federal listings: https://www.usajobs.gov (search "CDRH medical officer")
Want everything? FDA's full device database index is here: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
Questions about any of these pathways or about what regulatory service is actually like from the inside? I spent nearly twenty-five years there and youcan reach me through the contact page by clicking here: Contact or get in touch directly via this link: Get in touch.
— Binita S. Ashar, MD, MBA, FACS, MAMSE