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US FDA Invites Comments On How It Collects Device Info Through Q-Sub Program

 
• By Brian Bossetta

The US agency’s Q-Submission Program provides medical device manufacturers the opportunity to receive information on the regulatory process related to devices in development.

FDA Clock and Binder
• Source: Shutterstock

The Food and Drug Administration has opened a 60-day public comment period on how it collects information associated with the Q-Submission (Q-Sub) Program for medical devices, a tool aimed at giving device developers a better grasp of what regulators are looking for in the review process.

The FDA is seeking comment on four topics:

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