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What is 510k FDA approval?

FDA 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).

How much does it cost to get FDA approval?

The trials that help drug makers win FDA approval have a median cost of only $19 million. A lthough developing a new drug is generally considered to be a pricey proposition, the median cost of the pivotal trials needed to win regulatory approval is just $19 million, according to a new study. In other words, the key scientific evidence used...

What is 510 k process?

FDA’s 510(k) pre-market review process for medical devices provides strong protections to American patients and promotes medical innovation. It provides FDA the flexibility it needs to ensure the safety and effectiveness of low- and moderate-risk medical devices whose risks are well-understood from experience with similar devices.


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