MEDICAL DEVICE BLOG

RECENT POSTS

FDA Warning Letters Week of 3/1/2020: Device Design Controls, HCT/P

Enforcement this week included a collection of warning letters including three device warning letters and three drug GMP warning letters, including one to a fertility clinic governed under 21 CFR 1271. And, warning letters to firms touting treatments for the coronavirus disease finally started appearing.

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GMP Compliance for Legacy Products: How to Find and Avoid Potential Quality Issues

FDA-regulated firms face an enormous challenge keeping up with agency priorities and expectations—especially companies that produce older products within an ever-changing regulatory landscape.  While firms continue to manufacture these older products to serve their customers and protect their brand, there are many potential quality compliance issues that can arise.

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Govzilla 510k 101

510(k) 101

The FDA 510(k) Program, also referred to as premarket notification, is an FDA marketing clearance application and is the most common avenue of premarket submission for medical devices. This article serves to provide you with a high-level understanding of the items required in 510(k) submissions and resources to help you during the process.

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FDA WARNING LETTERS

FDA FORM 483s