What “FDA-approved” does and doesn’t tell you

The claim reader flags phrases like these, wherever they appear in an ad:

• “FDA-approved”
• “FDA approved”

• The exact product or device name
• What it was approved or cleared for, in FDA’s words
• Whether what they’re proposing for you matches that use
• The application number, which you can look up in FDA’s databases

Could be measured. This is a real question with a real answer. Ask it, and ask for the answer in writing.

Regulatory. Authority borrowed from a regulator. Ask what exactly was approved or cleared, and for what use.

FDA describes more than one route to market for medical devices. The highest-risk devices generally need premarket approval; many moderate-risk devices are marketed through what FDA calls “510(k) clearance.” So a device can be cleared rather than approved.[1]

• Look up a product or device

Paste an ad, a post or a DM. It’s read in your browser, and nothing is sent anywhere.

• What “medical-grade” really means
• “FDA-registered” is not “FDA-approved”