MedTech Crossroads

Does the FDA Regulate Tattoo Guns?

Discover more about tattoo guns and the FDA in this MedTech Crossroads webinar. Gene Parunak, Managing Director at in2being, begins this episode with a discussion of tattoo equipment. Because tattoo guns don’t meet the FDA’s definition of a medical device, they’re not regulated as such. The FDA considers tattoo inks to be cosmetics; consequently, they don’t need to be approved—only monitored for adulteration or misbranding. Tattoo parlors are regulated at the state level. Interestingly, laser tattoo removal devices are considered Class II medical devices because they affect skin structure and function. As a result, they typically need FDA clearance through a 510(k) submission. Microneedling devices may or may not need FDA clearance; the issue hinges primarily on whether or not they do more than superficial exfoliation.

FDA Guidance on Off-the-Shelf Software

In the show’s second half, Gene reviews the FDA’s new guidance on off-the-shelf (OTS) software use in medical devices. Although it’s tempting to use OTS software in your medical device, doing so means giving up control of the software lifecycle. The FDA requires OTS software to be well-documented. Many of the design control standards that apply to medical device hardware also apply to software. When OTS software is updated, companies must evaluate the changes to determine if a new 510(k) submission is warranted.

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