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Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of […]

Did You Know That Sunglasses Are Regulated by The FDA As Medical Devices?

Did You Know That Sunglasses Are Regulated by The FDA As Medical Devices?   Whether you import sunglasses into the United States or sell sunglasses in the U.S. commerce, you are required to comply with the laws and regulations of the U.S. Food & Drug Administration (FDA). The FDA regulates sunglasses products to ensure their […]

Does Your Medical Device Have a Unique Device Identification (UDI)?

We’ve previously kept you informed on how to determine whether your product is regulated as medical device by the U.S. Food and Drug Administration (FDA) and how to register your medical devices with the Agency. On June 2, 2017, FDA issued a letter to Device Labelers of certain classes informing of extended compliance dates for […]

WHAT DO CONTACT LENSES, DENTAL FLOSS, AND PACEMAKERS HAVE IN COMMON?

Who knew dental floss was a medical device regulated by the U.S. Food and Drug Administration (FDA)? What about contact lenses, sunglasses, tongue depressors, dental floss, or bedpans? How about pacemakers? You guessed it, they all are! One might naturally think of a product like a defibrillator as a medical device, but in our business, […]

FDA Launches New Webpage to Promote Use of Symbols in Labeling of Medical Device

Today the U.S. Food and Drug Administration (FDA) launched a new webpage to assist the public understand the Use of Symbols in Labeling Final Rule. The final rule was issued by the FDA in June 2016 and became effective three months later. FDA intends the final rule to be an attempt to “harmonize the U.S. […]

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Want to discuss a new or existing matter? Contact DTL at info@diaztradelaw.com or 305-456-3830.