FDA Proposes eSTAR for PMA Submissions

MedTech Leading Voice - Issue 183

📝 From the Editor

On September 18, FDA issued draft guidance proposing eSTAR as the electronic submission format for PMA applications and supplements. Michelle Lott and Marina Daineko both covered it this week. Martin King's roundup carries the detail: technical screening within 15 calendar days, and up to 360 days to respond if a submission fails.

— Sean Smith

🧠 Featured Post

FDA's proposed eSTAR requirements for PMA submissions

Michelle Lott clarified FDA's proposed eSTAR requirements for PMA submissions and what they mean for review readiness. Under the draft, a submission that fails technical screening goes on hold, and resubmission restarts the review clock at Day 0. Once the guidance is final, FDA intends a transition period of at least one year. After that, designated applications not submitted electronically will not be considered received unless an exemption applies.

The scope covers Original PMAs, Panel-Track, 180-Day and Real-Time Supplements, and 30-Day Notices/135-Day Supplements.

PMA Modules and Modular Shells are excluded. Marina Daineko summarized the same eSTAR update in her weekly Monday News, and Martin King's roundup lists the draft under FDA. Comments are due within 60 days of the Federal Register notice. Any team with a PMA in the pipeline should read this before starting its next submission.

View the post >>

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

• EU MDR Compliance broke down the requirements for corrections, FSCAs, and field safety notices.
• Dr. Irene Thomas underscored the risk of AI creating competency gaps in regulatory affairs
• New EHDS requirements for cross-border identification and authentication were announced by Danny Van Roijen.
• MDx CRO traced the evolution of companion diagnostics and their role in targeted treatment decisions.
• FDA's evolving regulatory approach for generative AI-enabled medical devices, explored by Khalil Thomas.
• Josa Hanzlik discussed the FDA's shift toward non-animal testing and its implications for medical device safety evaluation.
• The landscape of over 1,600 FDA-authorized AI medical devices was analyzed by Bertalan Meskó.
• Sigrid Berge van Rooijen underscored the role of data quality and patient access in successful EHDS implementation.
• New FDA draft guidance for robotically assisted surgical devices was outlined by Stefano Bolletta.
• In her weekly Monday News, Marina Daineko summarized recent FDA updates on biocompatibility and PMA eSTAR requirements.
• Georg Digel addressed the risk and documentation considerations involved in extending CAPA timelines.
• Michelle Lott clarified FDA's proposed eSTAR requirements for PMA submissions and their implications for review readiness.

🎯 Featured Event

Tuesday, September 29, 2026, 11:00 AM ET — Sex Bias in Medical Device Usability Testing: The Human Factors Risk

Women made up about a third of participants across 195 medical device trials. In a 2019 ICIJ analysis of 340,000 FDA device injury and death reports, 67% of the people harmed were women.

A usability study can recruit an even split of men and women, pass every task, and still ship a failure that only affects some of them, because nobody cut the results that way. Aarti Swaminathan, Human Factors Manager at ClariMed, covers where sex bias enters design and testing. Diane LegereRN, BSN, MSc, APCCN, Clinical Evaluation Specialist at DNV, covers where it gets caught in review, and what post-market data shows when it was missed.

Register Now >>

🗓️ Upcoming Events & Webinars

• September 29, 2026 | 11:00 AM ET — Sex Bias in Medical Device Usability Testing, featuring Aarti Swaminathan (Human Factors Manager, ClariMed) and Diane Legere RN, BSN, MSc, APCCN (Clinical Evaluation Specialist, DNV). Register Now >>
• September 30, 2026 | 12:00 PM ET — Device Innovation to Commercialization, Phase 1: Concept. Seven Questions Before You Build a Medical Device, featuring Michelle Lott, RAC (Principal and Founder, leanRAQA) and Renae Franz (Commercialization Strategist, leanRAQA). Register Now >>
• October 2, 2026 | 11:00 AM ET — Compliant, and Still Wrong: The Human Side of Risk Decisions, a Friday In-Focus session featuring Steve Gompertz (Partner, Operations and Resourcing, QRx Partners) and Jean Blom (Quality Manager, Medical Devices, Medace BV). Register Now >>

🎟️ Upcoming Conferences

• 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 26–27 | Munich, Germany — The European Conference on Digital Transformation & Data in Medical Technologies (DTD2026), chaired by Clara Pessy of Platomics. Two days of keynotes, panels and industry symposia on AI-enabled medical devices, SaMD, regulatory innovation and clinical evidence generation, with Martin King among the speakers. MLV readers get 20% off registration with the code MEDTECH20. 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. Member rate $200. Register Now >>

💥 Weekly 510(k) Roundup

September 21, 2026 | From Marcus Engineering, LLC

75 clearances this week, including 30 first-time clearances (🚀).

Featured clearances:

• 🚀 OrbusNeich Medical Company Ltd.— JADE SCORE PTA Scoring Balloon Dilatation Catheter: helps open narrowed arteries in places like the legs and kidneys. A doctor guides the balloon to the blockage and inflates it. Small raised scoring elements press into tougher buildup as it expands, making more room for blood to flow.
• Johnson & Johnson MedTech— HARMONIC 1100 Shears: uses ultrasonic vibrations to cut tissue and seal blood vessels with one tool. That can help surgeons work more efficiently while limiting heat around nearby tissue.
• Elucid— PlaqueIQ: software that analyzes heart CT scans and shows what kind of plaque is in an artery, as well as how clogged it is. Softer, fatty plaque can be more likely to rupture and trigger a heart attack. That gives doctors a clearer picture of risk and a chance to act earlier.

Explore the update >>

📋 Regulatory Roundup

21 September 2026 | By Martin King

Martin King reads this week as a mix of requirements already in force and developments to assess, across medicines, medical devices and IVDs. Several need immediate attention:

• Health Canada's revised enforcement policy POL-0001 was implemented on 15 September.
• Egypt's bracketing and matrixing FAQ for stability studies took effect on 14 September.
• The European Commission's COMBINE guidance sets harmonised safety reporting for combined CTR/MDR/IVDR studies. Sponsors must receive SAE/DD reports within 24 hours, and specified device/IVD events go to NCAs within 7 calendar days.
• From 23 September, the Swissmedic Portal gives access to specialist data for complementary medicines.
• Egypt revised its customs-release procedures for devices and IVDs.

To assess, EMA's ICH E14/S7B (R1) Q&As apply from 23 October, and EMA's draft GI interactions guideline is open for comment until 31 December. Also in this group are Egypt's draft ATMP framework, new EU HTA JCA templates for patient, carer and clinical-expert input, and EMA's review of its API inspection programme. On the strategic watch list are the first eight European Digital Product Passport standards, HSA's expanded reliance cooperation with Saudi Arabia, Africa, Malaysia and the UK, and TGA guidance on computational modelling and simulation. The list also includes FDA's CDRH Regulatory Reliance Portal and MHRA and MDSAP updates. The index also covers HPRA's 2025 annual report, MedTech Europe's reaction to the EU Procurement Regulation, NIST IR 8587, NMPA's BCI EEG dataset standard, SAHPRA's registry and eCTD programme, FDA's PMA eSTAR and buffy coat guidance, and two WHO reports. This edition is a flipbook, with every source reachable by QR code or through the Index of Indexes.

Explore the update >>

🎤 In Case You Missed It

Testing Software to Prove It Works

Last Friday on Friday In-Focus, Kris Kelly, CEO of, opened with the rise of Class I recalls, up 232% between 2020 and 2025. He also covered the point most people get backwards: a Class I recall is not a Class I device. He then walked through his process for finding the failures requirements-based testing is not built to catch. It relies on cross-functional teams that put clinical, software, quality and support in one room to generate scenarios together. 239 registered and more than 130 joined live from 29 countries.

"Most Class I recalls are in Class II devices. And the recalls in this session are Class I, which means the FDA judged that somebody could have been seriously hurt or killed."

Kris Kelly, CEO, Keystone Medical Device Partners

Watch the replay >> | Download the slides >>

Sean 🐝