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Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission

This guidance provides recommendations to industry and FDA staff about the best practices of choosing a predicate device for a 510(k) submission. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

This guidance provides recommendations to industry and FDA staff about the best practices of choosing a predicate device for a 510(k) submission. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).
September 7, 2023

Yesterday, the FDA released the draft guidance “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission” This comprehensive document offers valuable insights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.

For any questions, you can contact our team of MedTech experts: medtech@asphalion.com

Or schedule a free 30-minutes meeting here: https://bit.ly/3NwVsNR

 

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