News & Analysis as of

Medical Devices Food and Drug Modernization Act

Arnall Golden Gregory LLP

Commissioner Agrees Industry Is No Beast of Burden; Provides Plan to Improve Least Burdensome Approach

The concept of “least burdensome” review is not new. Starting with the FDA Modernization Act of 1997 (FDAMA), the Food and Drug Administration has been directed to take the “least burdensome approach” to the premarket...more

Knobbe Martens

FDA Issues Final Rule on Use of Symbols in Labeling

Knobbe Martens on

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

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