Article | July 16, 2024

FDA Pathways To Medical Device Approval

Source: ProPharma
Choosing the correct pathway, difficult decision concept, confusion symbol-iStock-1173531479

Commercializing your medical device in the US market often necessitates submitting a marketing application to the FDA to achieve FDA Approval or Clearance. The specific contents of your FDA submission are dictated by the device's classification into Classes I, II, or III, which reflect varying levels of risk. Devices falling under Class I or II exemptions typically require only device registration and listing with the FDA, whereas Class II and III devices have multiple pathways to market.

This blog post will delve into the seven primary pathways available for bringing a medical device to market in the U.S. Typically, medical device companies engage with the FDA early in the process to select the optimal pathway, thereby minimizing time and costs.

While many default to the 510(k) pathway due to its commonality, exploring alternative options may prove beneficial based on your device's characteristics and intended use.

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