Q-Sub/Pre-Sub Pre-Submission Consultation
Q-Sub is a comprehensive pre-submission communication framework, with Pre-Sub being its most commonly used category.
Purpose of Pre-Submission Consultation
Obtain FDA's feedback on product development, test protocols, clinical trial design, classification route and other specific issues prior to formal submissions such as 510(k) and PMA.
Applicable Scenarios
Applicants with preliminary device classification conclusions may consult and confirm with FDA regarding classification rationality and corresponding test/data requirements under the determined classification.
Process
Submit requests via FDA Electronic Submissions Gateway (ESG). FDA conducts administrative RTA review. Upon approval, FDA provides feedback in writing or via formal meetings.
Fees
No filing fees are charged for Q-Sub/Pre-Sub submissions.
Key Differences from 513(g)
Unlike 513(g), Q‑Sub/Pre‑Sub is not designated exclusively for device classification rulings. It presupposes applicants have a tentative classification and is used to secure FDA technical guidance concerning performance testing protocols, clinical trial design or standard selection.
Strict language specifications apply to Q-Sub/Pre-Sub applications. Our regulatory consulting service can assist you in compiling professional dossiers for FDA submission to obtain guidance on testing specifications, submission pathways, clinical requirements and predicate devices excluding classification inquiries.
