Aug 31, 2023 · When creating an authorized co-branding/partnership logo composite for a FDA publication, the FDA Mark must be the first name or logo to appear — right justified in a horizontal configuration.

But how can you know for sure what the U.S. … must be truthful and not misleading. Misuse of the FDA’s logo may violate federal law. The FDA’s logo is for official …

Jul 26, 2018 · Generally, FDA “clears” moderate-risk medical devices (Class II) (for example dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval.

Mar 3, 2021 · How to know if a medical device is FDA-approved, cleared, or authorized. The FDA does NOT issue registration certificates.

Jun 2, 2019 · Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is "cleared," and can be marketed and sold in the US.

The FDA seem to “close their eyes” to companies using “FDA registered” of “FDA cleared” on their company websites and product advertising. We have recently observed that the FDA is not listing violations of the FDA regulations with using “FDA” logo …

Jul 5, 2022 · The manufacturer cannot claim the device is “FDA Cleared” or “Approved,” and they cannot use the FDA logo in marketing or labeling the device. The FDA can monitor the safety of products and devices registered to them through the MedWatch program .

Mar 5, 2021 · Even before COVID-19 brought an onslaught of new players to the FDA-regulated space, many sophisticated medical device companies used to include FDA’s logo on marketing materials to imply that FDA had endorsed their products.

Jan 17, 2020 · Registration simply means the FDA is aware of the manufacturer and their devices. The manufacturer cannot claim the device is “FDA Cleared or Approved”, and they cannot use the FDA logo in marketing or labeling the device.

Oct 14, 2024 · Food and Drug Administration adhered to a monogrammed logo in the middle of its activities. It contained the connected letters “F,” “D,” and “A,” which consisted of triple lines. Each mark’s base was a thin white middle, encircled on both sides by bold black stripes.