Theodore M. Sullivan quoted in article “FDA Moves to Help CMS With Device Coverage Decisions”Bloomberg BNA 06/01/16
Below is an excerpt:
The updates the draft guidance makes to the FDA's categorization process simplifies what was a complicated procedure, Theodore Sullivan, a Washington-based attorney at Quarles & Brady LLP, told Bloomberg BNA May 31.
Essentially, the device categorization process comes down to whether the product is safe and effective, Sullivan said. The draft guidance allows industry to focus on this question, instead of worrying about several subcategories that existed under the previous categorization process, he said.