Category: FDA 510(k) Submissions

FDA Proposes Expanding the List of 510(k)-Exempt Devices:
What You Need to Know

FDA List of 510k Exempt Medical Devices.

What: On March 14, 2017, FDA published a formal notice proposing to make hundreds of Class II medical devices exempt from premarket notification requirements that necessitate a 510(k) submission.* Note that there are a few exceptions for specific indications of medical devices. All devices will still need to meet other FDA requirements, such as 21 CFR 820 Quality System Requirements.

We view this shift as allowing FDA to focus its limited resources on higher-risk products in the 510(k) premarket notification pathway as well as the increasing number of 510(k) and de novo submissions being received.…

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All Topics, FDA 510(k) Submissions, US FDA 21 CFR Part 820 (QSR), US FDA Updates