Fast product launch new medical devices: 510(K) and FDA cleared v FDA approved

By Staff

Barriers for bringing new medical devices to market can be challenging. Balance between medical product outsourcing activity with contract manufacturing partners and medical device manufacturers is key. But FDA Cleared medical devices not only undergo less scrutiny than FDA Approved devices, they also require no proof the medical device actually works.

FDA Cleared devices can legally promise more than they deliver. The way most medical devices become cleared (v approved) is through a loophole in the FDA’s system called the 510(K) pathway. This can be good for medical device manufacturers wanting to get product to market quickly.

Find med device product development

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The Food, Drug and Cosmetic Act Section 510(k) mandates OEMs marketing medical devices need to register / notify the FDA at least 90 days in advance of the date the OEM intends to bring its medical device to market. (Read more at

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MedTech device and equipment trends

Technically, medical device companies bringing a new product to market are not required to go through a strenuous testing process if the new device being brought to the market is substantially similar to one that had come before. This way, innovation would not be stifled.

Contract service agreement for medical device design services
Contract service agreement for medical device manufacturing services

But abuse has taken hold, and as more consumers come to understand this, device manufacturers may want to take the extra steps when deciding which path to take when launchin med device new product introductions.

FDA Cleared or Approved devices (2017)

Surprisingly, today, more than 80% of medical devices are cleared through the 510(K) loophole. See below.

But first to market does not guarantee market share stability. Comedian John Oliver speaks to this on HBO’s ‘Last Week Tonight with John Oliver’.

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