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

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Small Business Determination (SBD)

Earn massive discounts on submission fees if you have less than $100M in receipts.

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Q-Submission (Pre-Sub)

A 70-day process to validate your testing plans before you spend money on execution.

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

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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

The New Rules of 2026

Your Arsenal: Two Power Tools

Small Business Determination (SBD)

Q-Submission (Pre-Sub)

Small Business Determination (SBD)

FY 2026 Fee Comparison

Qualification Process

The Q-Submission Strategy

Type 1: Pre-Sub

Type 2: SIR

Type 3: Study Risk

📅 The 70-Day Clock (Standard Pre-Sub)

Day 0: Submission

Day 15: Acceptance

Day 70: Written Feedback

Day 75-80: Meeting (Optional)

6 In-Depth Modules

FDA Overview

Steps to Market

Registration & Listing

510(k) Submissions

PMA & De Novo

Tools & Databases

Ready to Master the Regulatory Landscape?

Your 2026 Guidance Library