Yesterday, the FDA released the draft guidance “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission” This comprehensive document offers valuable insights and recommendations to streamline the premarket notification process, ensuring that medical device manufacturers select appropriate predicate devices for their submissions.
The premarket notification 510(k) process, commonly referred to as 510(k), is a regulatory pathway overseen by the FDA for the approval of medical devices. It requires MedTech manufacturers to demonstrate that their new device is substantially equivalent to an existing “predicate” device already on the market in terms of safety and effectiveness. It enables manufacturers to bring their products to market efficiently, thereby saving both time and costs compared with more extensive regulatory pathways.
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