Pearls of Wisdom
FDA to issue guidance on mobile medical devices
According to a recent article on Pharmatimes.com, the FDA plans to issue guidance describing which medical apps on mobile devices will be subjected to FDA approval. With the advent of multiple new medical apps, the FDA plans to regulate mobile devices that perform...
Health Canada issues a medical device final rule
Health Canada issued guidance on March 4, 2013 entitled “Factors Influencing the Classification of Products at the Device-Drug Interface” which finalizes the guidelines for classification of therapeutic devices or drugs. The focuses of the guidance were to clarify...
Caldwell to serve on IHIF April Lunch Series Panel
Pearl’s Diana Caldwell and other industry professionals will discuss the impact of the service sector on life sciences in Indiana at the April IHIF Lunch Series. Topic: “Indiana’s Life Science Service Sector” When: Tuesday, April 16, 2013 Time: 11:30-1pm Location:...
Health Canada to accept only electronic submissions
In an effort to reduce the costs, Health Canada announced that it is only accepting administrative regulatory submissions in either electronic common technical document (eCTD) format or as a Portable Document Format (PDF) file beginning June 1, per a recent article on...
FDA issues new draft guidance to clarify medical recalls from product enhancements
FDA recently issued draft guidance, entitled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements.” The guidance was issued to clarify when a change in a medical device product warrants a recall. Additionally, the...