FDA Announces Its Plan For Changes to the 510(k) "Approval" Pathway


January 19, FDA announced its plan to modify the 510(k) “approval” pathway, the most common review path for medical devices. Specifically, FDA released a report containing twenty-five actions it intends to take in 2011 to “improve” the review process. Importantly, however, no changes have yet been made to the process; FDA has just announced its plan of action of how it intends to address potential changes to the process.

A medical device manufacturer who wishes to market a device classified in Class II or, in limited cases, Class I or III, that it believes is substantially equivalent in both safety and effectiveness to a device already on the market (a “predicate device”) must make what is known as a 510(k) notification. Section 510(k) of the Federal Food, Drug, and Cosmetic Act (“FFDCA”) requires medical device manufacturers to notify FDA of their intent to market a medical device at least 90 days in advance of doing so. A 510(k) premarket notification allows FDA to determine whether the particular device is substantially equivalent in safety and effectiveness to a predicate device already being legally marketed. Many changes to medical devices previously cleared for marketing must also be submitted for review prior to implementation.

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