Monthly Archives: January 2018

FDA Delays Implementation of Changes to “Intended Use”

On January 16, 2018, the FDA announced that the Agency will be delaying implementation of parts of its “intended use” rule due to concerns raised by the industry. The FDA issued a Federal Register notice, attached here after the link, explaining that the delay of implementation would be “until further notice” and referenced a number […]

Dr. Mary Richardson Honored at ATHENA Awards Reception

Dr. Mary Richardson, iuvo’s Chief Scientific Officer, was honored Wednesday evening, January 17, 2018 at a reception with the other finalists for the 2018 ATHENA Awards. The ATHENA Award is presented by the Rochester Chamber of Commerce and honors professional women leaders who strive toward the highest levels of personal and professional accomplishments, devote time […]

Recent FDA Announcements – Accessories and Least Burdensome Provisions

There’s frequently a flurry of FDA announcement near the end of the year, and this year was no exception.  We wanted to highlight a couple of the more pertinent ones that may be of interest to our customers.  The summaries below link to some of the more interesting guidance documents recently released. In late December, […]