Editor’s note: This blog by affiliated attorneys John Johnson and Schevon Salmon was originally published by greenlight.guru. “This is a what” is not only a torturous summer-camp game, but an essential question when working to bring a medical device to market. An...
Recent headline: Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated Our take... Yeah...not so fast. I expect the Trump-team follow up to be, "we meant 75-80% of the really bad regulations will disappear -- and most likely only in...
Last October, FDA published a proposed rule regarding the electronic submission of labels and package inserts for home-use medical devices, which are defined as devices labeled for use outside a professional healthcare facility and include diabetic test strips,...
FDA essentially banned all powdered medical gloves in the United States starting on Wednesday, January 18, 2017. On that date, not only are the gloves no longer allowed to be manufactured or distributed, but also healthcare providers must dispose of their stocks too....
Between October 1 and December 31 this year, all FDA-registered facilities must renew their registrations. Our team has handled registration renewal for hundreds of facilities. Here are some of our best tips for ensuring the renewal season goes smoothly. Medical...
The FDA is coming! The FDA is coming! “This sums up my initial feelings in 2009, when I got the news that FDA was making a trip to our company,” recalls Schevon Salmon, an affiliated attorney. He was in charge of a medical device company’s compliance program during...
When it comes to leak testing for latex products (condoms, medical gloves), FDA is not infallible, and can be challenged. When testing for leak holes in shipments of imported condoms and medical gloves, the Agency adopts a composite sampling method, which increases...
If you manufacture wearable fitness trackers or electronic massagers, determining how your product will be regulated is an important exercise. An erroneous conclusion can have a substantial impact on your business. At the end of July 2016, FDA published a final...
The Food and Drug Administration (FDA) issued the final rule for using symbols in labeling of medical devices and certain biological products.[1] The rule will be effective mid-September 2016. Specifically, the new regulations allow symbols to “stand alone”, i.e.,...
Some manufacturers label or promote their products as “latex free” or “does not contain latex” to inform users that natural rubber latex in any of its forms was not used in their product. In a guidance document titled "Recommendations for Labeling Medical Products to...
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