Updated Guidance on the FDA Q-Submission (Q-Sub) Program  

The FDA’s updated Q-Submission (Q-Sub) guidance, issued on May 29, 2025, provides medical device and IVD manufacturers with a structured framework to engage proactively with the FDA before or during the regulatory submission process. This voluntary program is designed to improve communication, streamline regulatory pathways, and enhance the quality of submissions. With this publication, the “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” issued on June 2, 2023, and “Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies – for Use by CDRH and Industry,” issued on February 19, 1998, are revoked. 

Key Takeaways From the Updated FDA Q-Submission Guidance

• Early feedback: Manufacturers can gain regulatory clarity early in product development. 

• Shortened review timelines: High-quality, well-prepared submissions are more likely to progress smoothly. 

• Risk reduction: Helps identify and resolve potential regulatory challenges before formal submissions. 

• Supports innovation: Encourages strategic planning for novel and breakthrough technologies. 

Applicable Situations

• The guidance applies to both potential and submitted applications 

• The guidance is relevant to a wide range of submission types, including: 

• Investigational Device Exemptions (IDEs) 

• Premarket Approvals (PMAs) 

• Humanitarian Device Exemptions (HDEs) 

• De Novo Classification Requests 

• 510(k) Premarket Notifications 

• CLIA Waiver Applications (CWs) 

• Dual 510(k)/CLIA Waiver Submissions (Duals) 

• Accessory Classification Requests 

• Certain INDs and BLAs regulated by CBER under section 351 of the Public Health Service (PHS) Act 

• Responses from FDA may be provided in writing or the manufacturer can request a “meeting” with FDA, which may be conducted in-person (face-to-face) or virtually (by videoconference or teleconference). 

Key Q-Submission Types Explained 

Timelines for Feedback 

Summary of the Updated FDA Q-Submission Guidance

The updated Q-Submission guidance is considered a highly valuable tool for manufacturers seeking to navigate the regulatory landscape efficiently and effectively. By leveraging this guidance, manufacturers can ensure that their submissions are of the highest quality, thereby increasing the likelihood of a clear feedback from the FDA concerning questions raised.  

For detailed guidance and templates, refer to the full FDA document: FDA Q-Submission Guidance (May 2025). Note that to support FDA’s broader strategy to implement guided submission tools and templates for medical device submissions Pre-Subs can be submitted in an eSTAR format, where additional Q-Sub types may be included in the future. Note that the use of eSTAR format is currently on a voluntary basis. Upon finalization of the Draft Guidance on Electronic Submission Template for medical Device Q-Submissions the FDA plans to allow a minimum 1-year transition period post-finalization before mandatory use. 

Expert Support for Your FDA Q-Submission Strategy

If you have any questions regarding this summary or the accompanying guidance document, we encourage you to reach out to our regulatory experts, here. We are here to assist you with your Q-Sub strategy and submission preparation, and we can help you identify the most effective regulatory strategy for your products.