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Food and Drug Administration (FDA) › Device Classification

Arnall Golden Gregory LLP

There Must Be Some Misunderstanding: FDA Issues a Warning Letter to a Medical Device Company That Made the Wrong Decision on...

Arnall Golden Gregory LLP on

In 1980, the British rock band, Genesis, released “Misunderstanding.” Forty-three years later, the Food and Drug Administration and a medical device company fell into a misunderstanding about a product’s regulatory...more

Mintz - Health Care Viewpoints

Things to Consider When Determining the Regulatory Requirements for Software (Hint: It’s More Than the Device Classification)

Mintz - Health Care Viewpoints on

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are...more

ArentFox Schiff

Devil Is Always in the Details: FDA Updates Device Classification Regulations To Remove Certain Software Functions

ArentFox Schiff on

On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products. This final rule takes...more

Hogan Lovells

FDA Issues Long-Awaited Final Guidance on When a Device Modification Requires a New 510(k)

Hogan Lovells on

Six years after its first attempt to update its now 20-year-old guidelines for when modifications to a 510(k)-cleared device require the submission of a new 510(k) notice, the U.S. Food and Drug Administration (FDA or the...more

Hogan Lovells

Is it a drug, device, biologic, or combination product? FDA issues final guidance on classification

Hogan Lovells on

On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device, biological product, or a combination product,...more

Butler Snow LLP

Pro Te: Solutio Vol. 8 No. 2

Butler Snow LLP on

Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations. Generic preemption remains a hot topic. In Storm...more

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