USA Market
Q-Submission Consulting
Medical Device
IVD
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What is Q – Submission Consulting?
Q-Submission Consulting services are offered to medical device manufacturers and developers who intend to seek regulatory guidance and interact with the U.S. Food and Drug Administration (FDA) through the Q-Submission program. The Q-Submission program provides a formal mechanism for industry stakeholders to obtain feedback from the FDA on various aspects of their medical device development, including regulatory strategy, study design, clinical trial protocols, and more.
Why is Q – Submission Consulting important?
Q-Submissions are a valuable tool for manufacturers to proactively seek regulatory guidance, clarify regulatory expectations, and align their device development and regulatory strategies with FDA requirements.
Q-Submission consulting is important for following reasons:
- FDA Interaction
- Regulatory Strategy
- Efficiency
- Risk Mitigation
- Compliance
Process Flow for Q – Submission Consulting
Determine the need for Q-Submission
Selection of Regulatory Consultant
Preparation and Compilation
Submission to FDA
FDA Review and Meeting Coordination
FDA Response
Action Plan Development
Data Generation and Collection
Regulatory Strategy Implementation
Quality and Compliance
Post Market Activities
How can we help in Q – Submission Consulting?
The CliniExperts’ professionals will:
Provide a structured way to interact with the FDA early in the device development process, reducing the risk of regulatory roadblocks and uncertainties later on.
Help manufacturers develop a clear regulatory strategy based on FDA feedback, increasing the likelihood of successful device approval or clearance.
Lead to more efficient regulatory processes, shorter time-to-market, and cost savings.
Assist in identifying and addressing potential regulatory and clinical risks, reducing the likelihood of delays or regulatory issues.
Regulatory requirements for Q – Submission Consulting
Documents
Q-Submissions typically do not involve specific form names, but they may involve submission of specific documents, which can include:
- Cover Letter
- Device Description
- Regulatory Strategy
- Questions and Discussion Topics
- Supporting Documents
Timeline
The timeline for a Q-Submission can vary depending on factors like the complexity of the device, the type of Q-Submission, and the FDA’s workload. The FDA aims to respond to Pre-Submissions within a specified timeframe, but response times may vary.
Regulatory Body
The regulatory body responsible for Q-Submissions in the United States is the U.S. Food and Drug Administration (FDA). Manufacturers use the Q-Submission process to engage with the FDA’s Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER) for biologics.
Fees
There are fees associated with certain types of Q-Submissions, such as Pre-Submissions (Pre-Subs) and Pre-Sub Interaction Meetings. These fees can vary depending on factors like the type of submission and the size of the company. The FDA’s fee structure is subject to change, so it’s important to consult the FDA’s official website or contact the FDA directly for current fee information.
Validity
The validity of the consulting engagement extends as long as the manufacturer adheres to the FDA’s recommendations and strategies, provided that the device development and regulatory environment remain consistent with what was presented in the Q-Submission.
