FDA Pre-Submission and Q-Sub Strategy Consulting for Medical Devices

Deep Expertise Working with FDA Reviewers

The FDA Pre-Submission meeting is voluntary and free, and allows manufacturers to obtain FDA feedback before pre-clinical and clinical studies, or prior to a regulatory submission. NAMSA is the industry leader in guiding successful pre-submission meetings with the US FDA. Leveraging our team’s experience and strong working relationships with regulators, clients consistently place trust in NAMSA to accelerate clearance and approvals of innovative technologies. Not only do we understand how to obtain the most meaningful feedback possible throughout the Pre-Sub process, but we also possess unmatched experience on how to utilize pre-submissions to accelerate product approvals.

NAMSA’s team of medical device regulatory consultants puts their expertise to work for you. We have been involved in over 600 Q-Sub and Pre-Submission meetings for 510(k), De Novo, and PMA submissions. Our weekly interactions with the agency keep us up to date with agency expectations and help mitigate project risk. Our consultants ask the right questions during pre-submission meetings and focus on accelerating the approval process for your device.

FDA Q Sub Assistance

NAMSA takes a proactive approach to meetings with FDA. Our goal is to enhance the quality of your submission, reduce review time, and streamline your product development process.  Depending on your needs, NAMSA can assist with any of these of Q Submission situations plus the following:

• Developing a pre-submission strategy, scope and goals. This could be focused on getting feedback on the design of a preclinical study, clinical protocol synopsis or to clarify a regulatory pathway.
• Writing and compiling the pre-submission documents or providing guidance and review. This includes Q-sub type, method of feedback, meeting Information, purpose, device or product information, proposed indication for use, intended use or relevant regulatory history.
• Preparing the eSTAR submission to meet FDA submission expectations
• Assisting in preparing the client for the FDA meeting. This may include preparing a discussion agenda, practice sessions and reviewing FDA feedback (if applicable) prior to a face-to face meeting or virtual call with the Agency.
• Attending the FDA Pre-submission meeting with the purpose of discussing any feedback that is unclear or requires further clarification
• In collaboration with the client, we compile the meeting minutes and submit an amendment to the Q-sub package with in 15 days as required by FDA

Support for Numerous Types of FDA Submissions

Different types of Q-subs serve various purposes, such as addressing issues in premarket applications, determining study risk levels, and educating the FDA about new products. Specific Q-subs include Submission Issue Requests for addressing additional information requests or deficiencies, Study Risk Determination for assessing clinical study risks, and Informational Meeting Q-subs for product education. Other Q-subs include PMA Day 100 Meeting, Agreement and Determination Meeting, Breakthrough Device Designation Request, and Safer Technologies Program (STeP) inclusion. The FDA also recommends submitting a Q-submission (Q-sub) before a formal Accessory Classification Request and for obtaining feedback on Predetermined Change Control Plans (PCCPs) prior to premarket submission.

NAMSA’s deep team of FDA consultants have experience with all facets of FDA compliance, including strategy consulting, clinical trials, and documentation preparation in support of medical device submissions for:

• Investigational Device Exemptions (IDE)
• De Novo Submissions
• 510(k) Premarket Notifications
• Premarket Approvals (PMA)

Unlike most regulatory consultancies, NAMSA is also a leading medical device preclinical and contract research organization. This means that we can fully support your preclinical, clinical and testing needs.