Category Archives: News

Foreign Manufacturer of Surgical Masks Hit With FDA Warning Letter

The U.S. Food and Drug Administration (FDA) recently issued a warning letter to a manufacturer of surgical masks.  The manufacturer, located in Taiwan, was subject to inspection by the FDA that revealed numerous violations of the Federal Food, Drug, and Cosmetic Act (the act).  The FDA determined that the masks (medical devices) were adulterated and misbranded under the act. Violations included failure to conform with current good manufacturing practice requirements of the Quality System found at Title 21, Code of Federal Regulations (CFR), Part 820;…

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Google Glass v. HIPAA

It is too soon to tell how fast and how far the Google Glass trend will spread.  We have all signed the HIPAA disclosure forms and seen the cover page over the sign-in sheet that “keeps us from seeking the other patients’ name” at the doctor’s office. Will we soon be asked to check our Google Glass at the door?  Reportedly, the Google Glass only needs a line of sight to record images.  If that is true, then wearing the newest, coolest tech gadget could…

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Google Glass – Through a Different Lens

EP Global Communications, Inc. claims that it is in the process of filing over 50 patents to protect a new wave of smart technology. EPGL claims that their technology will allow doctors to use a device such as a Google Glass to view feedback data in real time while performing surgery.  It remains to be seen what specific technology the full arsenal of patents will seek to guard, but we know that their focus appears to be on hands-free technology with a variety of applications.…

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A Potential Godsend to Mothers-to-Be

After a 30-year hiatus, the Food and Drug Administration (FDA) has once again approved a drug to specifically treat morning sickness.  Diclegis, made by Canadian Duchesnay Inc., is scheduled to be available in June 2013.  Diclegis combines Vitamin B6 and antihistamine doxylamine in a time released formula to prevent nausea before it sets in. The same drug combination was marketed as Benedectin from the 1950’s to 1980’s.  Despite no conclusive medical evidence that it caused birth defects and court rulings in its favor, Merrell Dow…

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Medical Device Tax – What is It?

The medical device tax is a 2.3 percent excise tax on the sales price of taxable medical devices.  The tax applies to almost all FDA registered devices.  Those devices range from hip implants to tongue depressors.  The medical device tax has been compared to excise taxes on tobacco and alcohol products. Who is paying this tax? The manufacturer or importer, with limited exceptions.  Thus, companies are losing 2.3 percent off the top of their margins.  Commentators argue that the tax will thwart invention. Others argue…

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