Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
March 2, 2025
Approximately 5 minutes
Understanding the FDA Q-Submission (Q-Sub) Process and Pre-Submission Guidance
Understanding the FDA Q-Submission (Q-Sub) Process
The Q-Submission (Q-Sub) process, most commonly used in the form of a Pre-Submission (Pre-Sub), is an essential communication channel that allows medical device manufacturers to obtain formal feedback from the U.S. Food and Drug Administration (FDA) before submitting a premarket application.
The submission is called a Q-Sub because the FDA assigns it an identification number starting with the letter 'Q'.
🤝 The Pre-Submission (Pre-Sub) Program
The Pre-Sub program (formerly known as the Pre-IDE Program) allows manufacturers to discuss and obtain regulatory feedback from FDA experts regarding specific aspects of their device development, testing, or regulatory strategy. While this program is not mandatory, early interaction with the FDA is highly encouraged to streamline the development process and improve the quality of the subsequent formal submission (510(k), PMA, or IDE).
When to Use a Pre-Sub: A Pre-Sub meeting request must be submitted before beginning the clinical study, or before submitting the final 510(k) or PMA application on which feedback is being sought.
Devices that Benefit Most: The Q-Sub process is particularly valuable for:
- Devices utilizing novel technologies.
- Devices with indications that qualify them as "first of a kind."
- High-risk devices requiring an Investigational Device Exemption (IDE) for clinical investigation.
Key Discussion Topics: Topics that can be addressed via the Pre-Sub process include:
- The appropriate regulatory pathway (e.g., 510(k) vs. De Novo).
- Specific preclinical performance testing protocols required for clearance or approval.
- The formal designation of a clinical study as "significant risk" (SR) or "non-significant risk" (NSR).
📝 Q-Sub Submission Content
A successful Q-Sub package must be comprehensive and include specific, targeted questions for the FDA. Required contents typically include:
- Cover Letter
- A thorough device description detailing its proposed intended use, mechanism of action, and technological characteristics.
- The planned testing strategy (clinical and non-clinical).
- A list of specific questions for which the manufacturer is requesting the FDA's input.
The meeting with the FDA can take place via a face-to-face meeting, a teleconference, or simply a written response via email, depending on the complexity of the device and the nature of the questions posed.
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
US FDA Establishment Registration and Device Listing (FURLS) Requirements
Annual **Establishment Registration** and **Device Listing** with the US FDA is mandatory for most facilities involved in manufacturing, importing, or reprocessing devices for the US market. Registration is completed via the online **FURLS** system, and listing is generally required unless the entity is an Initial Importer.
Approximately 5 minutes
US FDA Clearance Pathways: Classification, QSR, and the 510(k) / PMA Process
All medical and IVD devices for sale in the US must follow the FDA's regulatory process, which involves risk-based classification (Class I, II, III), compliance with the Quality System Regulation (QSR), and securing premarket authorization through 510(k) or Premarket Approval (PMA).
Approximately 5 minutes
US FDA Medical Device Classification: Risk-Based System and Pathways for Novel Devices
The US FDA classifies medical devices into Class I, II, or III based on risk, using a predicate-based system. Most Class II devices require a 510(k), while Class III requires Premarket Approval (PMA). Novel devices lacking a predicate may pursue classification via a 513(g) Request or the De Novo pathway to avoid automatic Class III status.
Approximately 5 minutes
How Long is the FDA Review Process for 510(k) Medical Device Submissions? (MDUFA III Goals)
The FDA's goal, per MDUFA III, is to issue a final clearance decision for most 510(k) submissions within **90 calendar days**. Key milestones include acceptance review within 15 days and substantive review decisions within 60 days, providing manufacturers with a predictable communication timeline.
Approximately 5 minutes
US Medical Device Clearance: The Predicate Pathway and FDA's Regulatory Philosophy
The US FDA emphasizes different regulatory barriers than the EU. The **510(k) pathway** often allows clearance based on demonstrating **substantial equivalence** to a predicate device, representing a distinct philosophy focused on comparative safety and effectiveness rather than the continuous, stricter clinical evaluation required by the EU MDR.
Approximately 5 minutes
Technical Overview: The FDA ANDA Process for Generic Drug Approval
The Abbreviated New Drug Application (ANDA) is the FDA pathway (Section 505(j)) for generic drug approval, requiring demonstration of **pharmaceutical equivalence** and **bioequivalence (BE)** to a Reference Listed Drug (RLD). The process involves RLD identification, Q1/Q2 formulation, BE studies, stability testing, and eCTD submission under GDUFA.