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510(k) Premarket Notification – A Passport for Market Entry

There are some important requirements for establishing SE. The flowchart below lays out, at a high level, the decision making process that the FDA employs to come to a decision of SE or NSE (Non Substantially Equivalent). Every person who wants to market a medical device in the United States, be it a Class I,…

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5 tips for a successful 510(k) submission

A medical device, before being released into the interstate US commerce, needs to pass the fastidious scrutiny of the FDA. Apart from the devices in class III, which require a PMA, for few of the devices in class I and most of the devices in class II, submitting a Premarket Notification or a 510(k) is…

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510(k) flowchart

FDA has laid out characteristics essential for the review of 510(k) submission. It is important to be aware of the following flowchart before the actual submission is made : For more information on how to navigate through the flow chart, please feel free to contact us at contact@elexes.com.

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510(k) is a pre-market submission filed at the FDA by the manufacturer who intends on  releasing a medical device into the market. A 510(k) basically demonstrates that the device to be marketed is, if not superior, at least as safe and effective as the the device to which it is substantially equivalent. It is essential…

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