USFDA’s Med Dev Guidance: The Q-Submission Program & Electronic Submission Template for Medical Device Q-Submissions
- Sharan Murugan
- May 30
- 2 min read
As medical technology advances, the FDA’s regulatory frameworks continue evolving to ensure timely, safe, and effective device development. For companies planning to submit medical device applications—ranging from investigational studies to market authorizations—the FDA’s Q-Submission Program (Q-Sub) offers structured opportunities to obtain feedback early in the process.
Recently updated guidance documents provide greater clarity on the Q-Sub process and introduce a significant digital upgrade: the Electronic Submission Template and Resource (eSTAR). This blog post explores the two interrelated guidance documents:
The Q-Submission (Q-Sub) Program
The Q-Submission Program, managed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), allows device developers to engage with the FDA early in the product lifecycle.
Types of Q-Submissions:
Pre-Submissions (Pre-Subs): Formal requests for FDA feedback before submitting a formal regulatory application (e.g., 510(k), PMA, De Novo).
Submission Issue Requests (SIRs): Responses to deficiencies or questions from an FDA hold letter.
Study Risk Determinations: Requests for FDA's assessment of whether a clinical investigation presents significant or non-significant risk.
Informational Meetings: Meetings to share data or strategies with FDA, without expecting feedback.
PMA Day 100 Meetings: Required meetings between sponsors and FDA to review issues post-PMA filing.
Other Q-Sub Types: Includes interactions from Breakthrough Devices Program, Safer Technologies Program (STeP), and Accessory Classification Requests.
Q-Subs are voluntary but recommended to reduce submission risk and ensure efficient product development. They help identify potential regulatory pitfalls, clarify data expectations, and streamline FDA review.
For full details: FDA Q-Submission Program Guidance (May 2025)
eSTAR: The Electronic Submission Template
To modernize and simplify Q-Sub processes, the FDA introduced eSTAR (Electronic Submission Template and Resource)—a structured, dynamic PDF tool guiding users through required content for electronic Pre-Submissions.
Key Features of eSTAR:
Pre-populated fields and dropdowns using FDA-recognized standards
Links to relevant guidance documents and regulations
Automated completeness checks
Alignment with FDA’s internal “SMART” review template
Currently, eSTAR is only available for Pre-Subs, with future expansion expected. Developers can download the PreSTAR template to prepare submissions that meet technical review standards without needing paper copies or eCopies.
Full guidance available here: Electronic Submission Template for Medical Device Q-Submissions (May 2025)
eSTAR resource page: Voluntary eSTAR Program
Feature | Q-Submission Program | eSTAR Template |
Purpose | Facilitates structured FDA feedback | Streamlines digital Pre-Submissions |
Formats Supported | Written and/or meeting-based interactions | PDF-based guided template (Pre-Subs) |
Submission Types Covered | Pre-Subs, SIRs, Study Risk, etc. | Pre-Subs (expanding soon) |
Benefits | Early FDA engagement, risk mitigation | Faster processing, fewer technical holds |
Future Expansion Planned | More Q-Sub types and digital tracking | Additional submission types via eSTAR |
The Q-Submission Program and eSTAR template reflect the FDA’s commitment to modernizing medical device regulation. Together, they offer manufacturers powerful tools for engaging the FDA early and submitting complete, well-organized information electronically.
Reference Documents
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