New entry at Asphalion’s MedTech Blog | Key considerations and tips for submitting good submission files to regulatory authorities

September 27, 2023

Asphalion expert Adi Ickowicz explores key considerations and provides valuable tips for preparing and organizing submission files to ensure a smooth and successful regulatory approval process for your medical device.

Asphalion MedTech Blog | Your gateway to the medical devices world

September 13, 2023

Welcome to Asphalion’s MedTech blog! Our blog aims to serve as your go-to source for regulatory insights and tips related to medical devices that we

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

September 7, 2023

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).

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New entry at Asphalion’s MedTech Blog | Key considerations and tips for submitting good submission files to regulatory authorities

Asphalion MedTech Blog | Your gateway to the medical devices world

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

Did you miss the Webinar on EUDAMED MODULE 2? We got you covered!

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Related news and events

New entry at Asphalion’s MedTech Blog | Key considerations and tips for submitting good submission files to regulatory authorities

Asphalion MedTech Blog | Your gateway to the medical devices world

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

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