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2026 MedTech Regulatory Navigator MedTech Navigator Overview SBD Strategy Q-Submission USFDA Mastery Join Course ☰ Overview SBD Strategy Q-Sub Strategy USFDA Mastery Join Next Webinar The New Rules of 2026 As of February 2, 2026, the "Old Way" of FDA submissions is dead. With the QMSR (Quality Management System Regulation) active and MDUFA V fees at an all-time high, you need a precise strategy. Standard PMA Fee $579,272 Can be $0 with waiver SBD Deadline July 31 For FY 2027 qualification New Q-Sub Format PreSTAR eSTAR Version 6.x New Regulation QMSR ISO 13485 Alignment Your Arsenal: Two Power Tools 💰 Small Business Determination (SBD) Earn massive discounts on submission fees if you have less than $100M in receipts. Explore SBD Strategy → ⏱️ Q-Submission (Pre-Sub) A 70-day process to validate your testing plans before you spend money on execution. Explore Q-Sub Strategy → Small Business Determination (SBD) Secure the $20,000+ discount. FY 2026 Fee Comparison Qualification Process 1 Get Org ID in FDA User Fee System. 2 Complete Form 3602N (Domestic: Form 3602). 3 Upload tax returns via CDRH Portal. Hard Deadline: July 31st Renewal is mandatory every fiscal year. The Q-Submission Strategy De-risking your FDA submission through proactive dialogue. Type 1: Pre-Sub The most common. Used for specific feedback on bench testing, clinical protocols, or regulatory pathways. Type 2: SIR Submission Issue Request. Used to discuss deficiencies found during an active 510(k) or PMA review. Type 3: Study Risk Used to determine if your clinical study is "Significant Risk" (SR) requiring an IDE application. 📅 The 70-Day Clock (Standard Pre-Sub) Day 0: Submission Upload PreSTAR (eSTAR) file via CDRH Portal. No user fee required for Pre-Subs. Day 15: Acceptance FDA confirms the lead reviewer and provides the target date for written feedback. Day 70: Written Feedback FDA provides formal written responses to your questions. This is the "Golden Document." Day 75-80: Meeting (Optional) A 1-hour teleconference to clarify the written feedback. Not for new questions. 6 In-Depth Modules Mastering the end-to-end US FDA landscape with practical, actionable expertise. Module 1 FDA Overview Fundamental overview of US FDA regulations specifically tailored for medical devices. Module 2 Steps to Market • Know Your Product • Confirm Device Status • Regulatory Pathway Determination • Practical Example Module 3 Registration & Listing • Requirements & Exemptions • Establishment Registration • DFUF User Fees • FURLS Navigation Module 4 510(k) Submissions • Types of 510(k) Submissions • Document Requirements • Review Timelines • Practical eSTAR approach Module 5 PMA & De Novo • Clinical Data Requirements • Risk-based Evaluations • MDUFA & SBD Program • Successful Application Best Practices Module 6 Tools & Databases • 21 CFR Exploration • TPLC & 510(k) Database • Important Guidance Links • Practical Search Exercises Ready to Master the Regulatory Landscape? Join our comprehensive "USFDA Mastery" course to dive deep into these modules with live guidance, real-world case studies, and templates. View Upcoming Webinars Learn & Master Course → Limited slots available for the 2026 Cohort ⚖️ Your 2026 Guidance Library Direct links to official FDA regulatory resources. 📄 MDUFA V User Fee Rates 📘 Q-Sub Program Guidance ⚖️ QMSR Final Rule (21 CFR 820) 🤖 PCCP for AI/ML Devices © 2026 MedTech Regulatory Navigator. Data provided for educational purposes only.

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The 2026 MedTech Founder’s Guide: Securing FDA SBDs and Winning Q-Submissions

Medical Device Rules, 2017 – Draft Amendments (Dec 2025)