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510(k) RTA Warning Letters Life Sciences

Arnall Golden Gregory LLP

Love Is Like Oxygen (Unless FDA Thinks You Get Too Much, You Get Too High): FDA Issues a Warning Letter to a Medical Device...

One of the catchiest songs written by the 1970s British glam rock band, Sweet, is “Love Is Like Oxygen,” released in 1978. The chorus includes the lyrics, “Love is like oxygen; you get too much, you get too high.” Apparently,...more

Goodwin

Avoiding Misbranding: Words Matter When Describing the Regulatory Status of 510(k) Cleared Devices and Registered Device...

Goodwin on

​​​​​​​When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably as these terms carry a particular meaning....more

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