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On August 1, 2014, FDA released draft guidance proposing to exempt from
premarket 510(k) review many low-risk medical devices. The guidance
lists 107 devices it intends to exempt, including portable air
compressors, fluid-filled teething rings, surgical lights, some
mobile medical apps, and obstetrical forceps.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
