FDA QSub 2025

FDA QSubmission Program 2025 Update: Key Changes & How AF Pharma Can Help as Your U.S. Agent

If you're preparing to submit a 510(k), De Novo, IDE, or PMA to the FDA, the QSubmission (QSub) Program is one of your most important tools for early communication with the agency. In May 2025, the FDA released an updated guidance document that reshapes how industry interacts with regulators before formal submission.

In this blog, we explain the key changes to the QSub program under the 2025 update—and how AF Pharma can act as your official FDA U.S. Agent, supporting all aspects of the process.

What Is the QSub Program?

The QSubmission Program allows manufacturers and sponsors to request FDA feedback and meetings before submitting formal regulatory applications. It includes:

• Pre-Submissions (Pre-Subs)

• Submission Issue Requests (SIRs)

• Study Risk Determinations

• Informational Meetings

• PMA Day-100 Meetings

• And other FDA feedback mechanisms (e.g., for Breakthrough Devices or STeP)

  
  

What’s New in the 2025 QSub Guidance?

The new guidance supersedes the 2023 version and introduces significant improvements in structure, clarity, and regulatory expectations:

🔹 1. Submitter Responsibility for Meeting Minutes

Submitters must now draft and submit meeting minutes within 15 days of any Pre-Sub or Q-Sub meeting. These minutes become part of the FDA record.

🔹 2. Expanded Use of Pre-Subs

The guidance encourages the use of Pre-Subs not only for clinical questions, but also for:

• Predetermined Change Control Plans (PCCPs)

• Payor engagement

• Device-led combination products

  
  

🔹 3. Enhanced Structure for Virtual & In-Person Meetings

Clear distinction between virtual vs. in-person meetings, including security requirements and recommended duration (typically 1 hour).

🔹 4. New Tracking for Specialized Interactions

More Q-Sub types are now tracked formally, including:

• Breakthrough Device Designation Requests

• STeP Interactions

• Accessory Classification Requests

  
  

🔹 5. Use of eSTAR & PreSTAR Templates

FDA now strongly encourages electronic submission using PreSTAR templates and the CDRH Portal, improving submission accuracy and processing speed.

Why Pre-Subs Matter

Engaging with FDA early can help you:

• Avoid costly delays or rejections

• Get alignment on clinical and non-clinical protocols

• Understand classification and testing expectations

• Clarify regulatory pathways for complex technologies

AF Pharma: Your U.S. Agent for FDA Submissions

If you are a foreign manufacturer of medical devices, you must designate a U.S. Agent under 21 CFR Part 807.40. As your U.S. Agent, AF Pharma provides:

✅ Official point of contact for FDA communications

✅ Pre-Sub and 510(k)/PMA planning support

✅ Review and formatting of your Q-Sub package

✅ Assistance with eSTAR, RTA, and eCopy formatting

✅ Support throughout the total product lifecycle

We are already helping clients worldwide submit Pre-Subs, 510(k)s, and Breakthrough requests, and we are ready to support your entry into the U.S. market.

Ready to Submit a QSub or Designate AF Pharma as U.S. Agent?

Whether you're preparing a Pre-Submission or a full FDA submission, early FDA engagement is key—and AF Pharma is here to support you every step of the way.

📩 Email us at: info@afpharmaservice.com🌍 Visit: www.afpharmaservice.com