The regulatory space for medical devices is always evolving. Manufacturers have to keep up not only with FDA regulations, but other countries’ rules not to mention keeping track of Brexit, U.K.’s pending departure from the European Union. As product steward and regulatory representative at Eastman Chemical in Kingsport, Tenn., it’s Tina Barrett’s responsibility to keep up with all of those changes.
“The government agencies will send out news blasts. I get quite a few a day from the FDA,” Barrett told Medical Design & Outsourcing. “And then there are some European newsletters. By getting those daily emails, I go through them every day to review and see what the changes are and if those are relevant to us or not. There are some really great medical device-focused consulting groups that will host webinars where they’ll have subject matter experts from the industry go through the changes in regulations, as well, and what those mean. The FDA also does a really great job of putting on webinars that are informational to explain things as well. Attending those gives a good introduction to the changes.”