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Food and Drug Administration (FDA) › Federal Food Drug and Cosmetic Act (FFDCA) › Exemptions

Holland & Knight LLP

FDA's Final Rule on Laboratory Developed Tests Comes with Controversy and Concerns

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) recent announcement of a final rule extending regulatory oversight to laboratory developed tests (LDTs) has sparked controversy. As discussed in a previous Holland & Knight alert,...more

Fox Rothschild LLP

Federal Court Rejects Exemption Request In One Of PA’s First Mask Mandate Cases

Fox Rothschild LLP on

In one of the first cases in Pennsylvania to address the great student masking debate, a federal court has rejected several arguments made by parents seeking to exempt their children from a universal mask requirement imposed...more

King & Spalding

FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)

King & Spalding on

Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary - On April 16, 2021, the Food and Drug Administration (“FDA”...more

Knobbe Martens

Certain Medical Devices Exempted from 510(k) Requirements

Knobbe Martens on

The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA...more

K&L Gates LLP

Vermont Act 120 and Beyond: Genetically Engineered Foods, Where Are We Now?

K&L Gates LLP on

On July 1, 2016, Vermont’s genetically engineered food labeling law is set to become effective. Act 120 and its implementing rule (Vermont Consumer Protection Rule 121) require food manufacturers to label food products that...more

Snell & Wilmer

FDA Issues Final Guidance on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

Snell & Wilmer on

On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved...more

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