ITMC Systems is a dedicated consulting firm offering expert guidance and support in US FDA Pre-submission (Pre-sub or Q-Sub) consulting services for medical device manufacturers. With an experienced team of regulatory professionals and former FDA experts, we are committed to assisting clients in navigating the Pre-sub process with precision and maximizing their chances of success.
You must formally request a Pre-Sub meeting with the FDA. The contents of your Q-Sub submission for requesting a meeting should include a cover letter, a thorough description of your medical device along with its proposed intended use, the mechanism of action on the body, its technological characteristics, your planned testing strategy, and specific questions on which you are requesting input from the FDA.
You must submit your Pre-Sub meeting request before submitting your 510(k) or premarket application (PMA) review process, or before beginning a clinical study on which you are seeking feedback. There are other 'Q-Sub' meeting types that allow you to meet with the FDA for different purposes (e.g., Submission Issues meeting during the review process). However these are not as common.
FDA Pre-Sub consulting is available for sponsors and manufacturers to obtain regulatory feedback on various medical device- or IVD-related applications, including Investigational Device Exemptions (IDE) necessary for high risk medical device clinical investigations, premarket notification (510(k)) submissions, and clinical or non-clinical study protocols.
Topics that may be addressed using the Pre-Sub process include, but are not limited to, the following:
The FDA Pre-Sub program can prove especially valuable for devices utilizing novel technologies, or those with indications that qualify them as "first of a kind" devices.
At ITMC Systems, we understand the importance of a well-prepared Pre-submission interaction with the FDA. Let us be your partner in achieving clarity and direction for your medical device development journey. Contact us today to get started.