News & Analysis as of

Draft Guidance › Compliance › Warning Letters

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

Arnall Golden Gregory LLP on

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

Alston & Bird

FDA Issues Draft Guidance on Post-Warning Letter Meeting Requests Under GDUFA

Alston & Bird on

On September 1, the Food and Drug Administration issued draft guidance for post-warning letter meeting requests under the Generic Drug User Fee Amendments. Our FDA Compliance & Enforcement Team outlines factors drug...more

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