New FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here’s How It Works.

In 2018, FDA cleared 3,000+ medical devices via the 510(k) process. An overwhelming majority of those devices (82%) went through the Traditional 510(k) process. Only 60 (less than 2%) went through the alluring “Abbreviated 510(k)” process. Why? Well, frankly there is very little that is “abbreviated” about that process, as it still requires the submitter to demonstrate “substantial equivalence” to a suitable predicate device. Now, however, FDA has finally done something to provide relief from this requirement – it released a new […]

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

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 […]