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June 22, 2021

Modernization of 510(k) – A major milestone to safer and better healthcare

More than 190,000 distinct medical devices are regulated by the FDA. Data from the years 2017 & 2018 indicates that about 3000, on average, low and moderate-risk medical devices received FDA...

June 3, 2021

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...

5 tips for a successful 510(k) submission
March 17, 2021

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 th...

510k
March 17, 2021

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 :

Source: FDA g...

510k
March 17, 2021

510(k)

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 mark...