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Manufacturers Federal Food Drug and Cosmetic Act (FFDCA) Final Rules

Troutman Pepper

FDA Issues Final Rule on Regulation of Laboratory Developed Tests

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After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more

McDermott+

FDA Issues Final Rule Regulating Many Laboratory-Developed Tests as Medical Devices

McDermott+ on

On April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule around the regulation of laboratory developed tests (LDTs), which are in vitro diagnostic products (IVDs) that FDA describes as...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s Final Rule on Intended Use: ‘Getting Right Back to Where We Started From’

On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more

Foley Hoag LLP

New Intended Use Rule Finalized

Foley Hoag LLP on

On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...more

Hogan Lovells

After a long and winding road, FDA finalizes much-debated “intended use” rule

Hogan Lovells on

On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical devices and 21 CFR § 201.128 for drugs. This updated final...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

Cozen O'Connor

FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels

Cozen O'Connor on

This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of...more

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