“FDA Approval”

Used a lot inappropriately.

Since 510(k) Clearances are for lower to moderate risk devices, the labeling of such devices as "FDA approved" (reserved for high risk devices) is misleading and constitutes misbranding (FD&C Act, Sec 502). Per the actual text in the US Food Drug & Cosmetic Act, Sec. 502 (21 U.S.C., Chapter V, Section 352):
A drug or device shall be deemed to be misbranded--
(a) False or misleading label. If its labeling is false or misleading in any particular.
Thus, a claim that a device requiring a 510(k) (low to moderate risk) is "FDA approved" (high risk) is misleading and prohibited. Similarly, a claim that a device that is 510(k) exempt (low risk) is “FDA approved” (high risk) is misleading and prohibited.

Additionally, any representation that implies official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding (21 CFR 807.97). Per the actual text in the Code of Federal Regulations, Title 21, Part 807.97:
Submission of a premarket notification in accordance with this subpart, and a subsequent determination by the Commissioner that the device intended for introduction into commercial distribution is substantially equivalent to a device in commercial distribution before May 28, 1976, or is substantially equivalent to a device introduced into commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II, does not in any way denote official approval of the device. Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.
Thus, the use of a 510(k) in marketing (e.g., device has received 510(k) market clearance) or the mention of complying with the premarket process (i.e., for 510(k) Exempt devices) is prohibited.

Likewise, any representation that creates an impression of official approval because of registration or possession of a registration number is also misleading and constitutes misbranding (21 CFR 807.39). Per the actual text in the Code of Federal Regulations, Title 21, Part 807.39:
Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.
Thus, a claim that a manufacturer is "FDA registered" is prohibited.

Additionally, component manufacturers/suppliers/vendors/contractors are prohibited from claiming they are "FDA registered" per 21 CFR 807.39 due to the fact that they do not register, list, or pay the annual user fee.

For additional information regarding the term “FDA approved”, please utilize the links “Is it really FDA Approved?” and “Labeling Requirements - Misbranding” below. It will also interest you to utilize the link “FDA Logo Policy” below.

Is it really FDA Approved?:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm

Labeling Requirements – Misbranding:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/GeneralDeviceLabelingRequirements/ucm052190.htm

FDA Logo Policy:
http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/ucm218116.htm

eg Restiffic

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