Looking Under the Hood: Five 510(k) Program Updates You Might Have Missed

ARTICLE SUMMARY:

FDA’s 510(k) program is undergoing a lot of changes. Some of the updates have been relatively prominent, while others are more below-the-radar. Here are five in the latter category.

Even small tweaks to FDA’s 510(k) program can have a tangible impact on a broad swath of the industry, as more than 3,000 devices are cleared through the pathway each year. At the moment, FDA is in the middle of rolling out a host of changes—some small, some a bit larger—to the 510(k) program, making it difficult to keep up.

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