FDA Updates Its Human Factors Guidance

MedTech Leading Voice - Issue 176

📝 From the Editor

On August 3, the FDA released an updated version of Applying Human Factors and Usability Engineering to Medical Devices, the document that has carried the agency's usability engineering expectations since 2016. Horacio M P. has the clearest short read on what changed.

Three days later, nearly 600 people registered for ClariMed's session on human factors validation planning, which tells you where the attention is right now.Watch the Replay >>

— Sean Smith

🧠 Featured Post

FDA's Revised Human Factors Guidance

Horacio M P. reviewed the key updates to FDA's revised Human Factors guidance for medical devices, released August 3. It is the first revision of the 2016 guidance and the shortest read available right now on what changed.

Human factors ran through the rest of the week too.

ClariMed's session on validation planning drew nearly 600 registrations, and Denise Forkey said on that call what the up-front work protects against: studies that get repeated, submissions that come back with questions, timelines that slip.

View the post >>

📌 This Week's Top Posts (In no special order)

• Horacio M P. reviewed key updates to FDA's revised Human Factors guidance for medical devices.
• The role of eIFUs in improving IFU distribution, compliance, and patient safety was examined by Matrix One.
• Georg Digel shared best practices for improving technical writing in NC and CAPA records.
• Internal audit preparation strategies for SaMD quality management systems were shared by Danny Kroo.
• FDA's confidentiality recommendations for medical device cybersecurity were explained by Jose Bohorquez.
• Miguel Angel Torres Tello highlighted post-market surveillance requirements in Mexico and registration pathways for medical devices in Costa Rica.
• In her weekly Monday News, Marina Daineko summarized recent FDA and WHO developments shaping biocompatibility and medical device regulatory practices.
• Harriet Kamendi discussed hidden quality system risks in Class III medical device development.
• Lessons from a recent FDA warning letter on aseptic practices and data integrity were revealed by Kieran Falvey.
• Christina Nimal overviewed the regulatory implications of the MHRA's new AI scribe guidance.
• New requirements in MDSAP Audit Approach Version 011 were announced by MedReg Consultancy LLP.
• Maurice Bouillard compared preclinical study requirements for EU CE marking and US FDA submissions.

🎯 Featured Event

The MedTech Audit Before the Audit

On Friday, August 14 · 11:00 AM ET, Danny Kroo of Docusys Corporation. Thirty years in device quality, fifteen of them auditing for BSI. Real audit situations go up on screen and the audience votes on where to look next. Where to look, and how to find it before MDSAP, your Notified Body, and FDA do.

Register Now >>

🗓️ Upcoming Events & Webinars

Friday, August 14 | 11:00 AM ET — The MedTech Audit Before the Audit, featuring Danny Kroo (Docusys Corporation). Register Now >>

Wednesday, August 19 | 11:00 AM ET / 5:00 PM CET — When Enrollment Stops, featuring Daniela Karrer (Donawa Lifescience). Four real studies that stalled, and what turned out to be wrong underneath each one. Register Now >>

🎟️ Upcoming Conferences

• Wednesday, August 26 | Philadelphia, PA — Project Medtech Startup Symposium, at Quorum at the Science Center, in collaboration with Penn Health-Tech. Use code MLV20 for 20% off. Register Now >>
• September 15–17 | Charlotte, NC — RAPS Convergence 2026 at the Charlotte Convention Center, with preconference workshops September 14–15. RAPS marks its 50th anniversary this year. Register Now >>
• October 29–30 | Prague, Czech Republic — TEAM-PRRC Annual Summit 2026, fifth edition, at the Hilton Old Town. The European meeting for Persons Responsible for Regulatory Compliance and regulatory affairs professionals in medical devices. Register Now >>
• November 3–5 | San Diego, CA — MedTech Strategist Innovation Summit San Diego 2026 at The US Grant Hotel. A medical device partnering and investment conference. Attendee registration covers all sessions, meals, networking, and the JuJama partnering app. Register Now >>
• November 10–11 | Philadelphia, PA — PhMTI 2026 Fall Seminar: Human + Machine, The Enduring Value of Information Professionals in the Age of AI, at the Sofitel Philadelphia at Rittenhouse Square. Members $200. Call for Papers is open. Register Now >>

💥 Weekly 510(k) Roundup

August 3, 2026 | From Marcus Engineering, LLC

61 clearances this week, including 16 first-time clearances (🚀).

Featured clearances:

• 🚀 Swift Sync— Sync AV II Temporary Pacing Catheter: a narrow tube threaded through a vein into the heart to help control the heartbeat. It sends electrical signals to both the upper and lower chambers, where most temporary pacemakers stimulate only the main pumping chamber, so the heart fills and pumps more naturally.
• Augmedics— xvision Spine System: an augmented-reality headset that helps surgeons place screws and other instruments during spine surgery. It displays a 3D map of the spine directly in front of the surgeon's eyes, so the planned path stays in view along with the surgical area.
• T&R BIOFAB— TnR Cranial Implant: a 3D-printed scaffold used to repair holes or damaged areas in the skull after surgery or injury. It is made from biodegradable materials that break down gradually as bone grows into its porous structure, supporting the repair first and then making room for the patient's own bone.

Explore the update >>

📋 Regulatory Roundup

August 3, 2026 | By Martin King

This week's Article Edition runs under the title Regulatory Affairs the Strategic Business Enabler of Healthcare Innovation, with a Copilot Link on each entry. Martin groups the week into five dominant themes: medical device software (MDSW) and digital health, artificial intelligence (AI) and cybersecurity, clinical evidence generation and post-market surveillance, international collaboration and regulatory reliance, and lifecycle management and regulatory excellence.

The authorities behind those entries include the European Commission, European Medicines Agency (EMA), European Union Agency for Cybersecurity (ENISA), Central Drugs Standard Control Organization (CDSCO), Medicines and Healthcare products Regulatory Agency (MHRA), Swissmedic, Health Canada, FDA, World Health Organization (WHO), Therapeutic Goods Administration (TGA), ISO and ANVISA, all continuing to move toward risk-based, internationally harmonised and digitally enabled regulatory frameworks. Martin also notes that individual regulatory posts publish as soon as developments are identified, so the complete Roundup can run more than a week behind the news cycle.

Explore the update >>

🎤 In Case You Missed It

Beyond the Protocol: A Realistic Resource and Planning Guide for Human Factors Validation Success

Denise Forkey, Leya Berquist and Kira Favakeh of ClariMed walked through six mistakes that sink human factors validation studies. Scoping, resourcing, recruitment, dry runs, moderator training, and the analysis time nobody budgets for.

Nearly 600 registered and more than 200 were live on the call.

Watch the replay >> · Slides >> · MedTech Usability Prep Kit >>

🔥 Postscript

"You can get seven of the eight FDA cybersecurity controls right and still have your 510(k) refused."

Jose Bohorquez, PhD, President of CyberMed, and Mohamad Foustok, Chief Security Officer, went through all eight FDA Appendix 1 cybersecurity control categories on Friday. Jose's article is live onMedTech Leading Voice, and questions posted on it get answered there.

Watch the Replay >>

Sean 🐝