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Manufacturers › 510(k) RTA › Premarket Approval Applications

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Goodwin

Modernizing the FDA’s 510(k) Program for Medical Devices: Selection of Predicate Devices and Use of Clinical Data in 510(k)...

Goodwin on

On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, consistency, and...more

Faegre Drinker Biddle & Reath LLP

Not Just a Rubber Stamp: FDA Revises Its 510(k) Refuse to Accept Policy

Faegre Drinker Biddle & Reath LLP on

Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product liability lawyers, judges, and juries. FDA...more

Wilson Sonsini Goodrich & Rosati

Court Holds the FDA Cannot Classify an Imaging Agent Medical Device as a Drug

Wilson Sonsini Goodrich & Rosati on

The legal definitions of a drug and a medical device set forth in the Food, Drug, and Cosmetic Act have some important overlapping provisions. Because of the overlapping provisions, theoretically the U.S. Food and Drug...more

Wilson Sonsini Goodrich & Rosati

FDA Finalizes Guidance on Special 510(k) Pathway

Wilson Sonsini Goodrich & Rosati on

The Food and Drug Administration (FDA) recently finalized its guidance on the Special 510(k) Program—an optional pathway to commercial medical devices that have been modified since their previous 510(k) clearance. The Special...more

Mintz - Health Care Viewpoints

FDA Introducing a Variety of Programs to Help Medical Devices Get to Market

Mintz - Health Care Viewpoints on

Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical devices in order to get them to market more quickly. Some of the FDA’s efforts have been highly visible, such as the...more

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