FDA Q-submission Consulting Overview
US FDA has various mechanisms to facilitate interaction with the Agency regarding various applications that can be submitted for medical devices of varied risk classes. The early engagement with the Agency is facilitated through the request for feedback or a meeting with the US FDA under the “FDA Q-Submission Consulting Program”. This program enables interaction with the FDA on study and data considerations to improve the quality of submissions, reduced review timelines, and avoidance of unnecessary pre-clinical or clinical studies. Furthermore, manufacturers can leverage the FDA pre-submission meeting and FDA Q-submission consulting services to enhance their comprehension of regulatory prerequisites and optimize their submission strategies for maximum effectiveness.
The applicants with an intention to apply for the below-listed applications may opt for an FDA Q-Submission Meeting before making actual submissions-
- Investigational Device Exemption (IDE) Applications
- Premarket Approval (PMA) Applications
- Humanitarian Device Exemption (HDE) Applications
- Evaluation of Automatic Class III Designations (De Novo requests)
- Premarket Notification (510(k)) Submissions
- Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW)
- Dual 510(k) and CLIA Waiver by Application Submissions (Duals)
- Accessory Classification Requests
The FDA Q-submission meeting can be taken up in person or through teleconference. Based on the intended outcome of the interaction, there are different types of FDA Q-Submission meetings for the applicant to choose from, such as:
- FDA Pre Submission Meetings (Pre-Subs)
- Submission Issue Requests (SIRs)
- Study Risk Determinations
- Informational Meetings
The device manufacturers find the whole process of the FDA Q-submission program overwhelming and challenging, owing to the below-listed reasons –
- Determining the objective and expected outcome from the meeting.
- Presenting appropriate device information
- Framing the correct set of questions
- Evaluation of available types of meetings and making the right choice
- Choosing an appropriate method of feedback
FDA Q-submission Consulting Expertise and Advantages
- Support for original, supplement and amendment Q-Submission
- Analysis of device documents
- Evaluation and finalization of appropriate meeting pathway
- Compilation of submission package
- Compilation of meeting package
- Meetings for medical device submissions
- Representation during the Q-Submission FDA Meeting
- Post Q-Sub activities
- In-depth understanding of FDA Q-Submission program and meetings process
- Previous experience of executing FDA Q-Submission projects for different categories of Medical Devices
- Offices based out of the US for better execution and communication.
