New FDA Draft Guidance Documents Stand to Alter the 510(k) Process for Medical Devices

Lexology October 3, 2023
Duane Morris LLP

The FDA recently released three draft guidance documents that aim to “modernize” the 510(k) premarket notification process. This process permits medical device manufacturers to market a new device in the United States provided that they can show it is “substantially equivalent” to a device that has already been cleared by the FDA (i.e., a “predicate device”). The 510(k) clearance pathway is used for the vast majority of devices that the FDA reviews as it recognizes a balance between promoting innovation and patient safety. Starting in 2018, the agency began to express an intent to modernize the pathway while still ensuring a proper balance of the dual aims of innovation and patient safety.

In issuing these new draft guidance documents, the...

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