FDA Issues Final Guidance on Q-Submission Program

May 8, 2019

The FDA has released final guidance on the forms of meetings and feedback devicemakers can request for various submissions under the agency’s Q-Submission program.

The guidance outlines the options available to drug sponsors seeking input from the FDA for investigational device exemption applications, premarket approval applications, humanitarian device exemption applications, De Novo requests, 510(k) submissions, clinical laboratory improvement amendments (CLIA) waivers, dual 510(k) and CLIA waiver by application submissions (duals), accessory classification requests and certain INDs and BLAs.

The agency said the guidance reflects agreed-upon changes related to scheduling pre-submission meetings and clarifies other elements of the Q-Submission program.

“Early interaction with FDA on planned nonclinical and clinical studies and careful consideration of FDA’s feedback may improve the quality of subsequent submissions, shorten total review times, and facilitate the development process for new devices,” the agency said.

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