Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Health Data Management, in “FDA Eyes Plan to Lessen Review Burden for Software Updates,” by Greg Slabodkin.
Following is an excerpt:
Similarly, Bradley Merrill Thompson, an attorney at Washington-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, applauded Shuren for his creativity.
“I rather like his idea. What he’s really saying is that he might consider focusing on capabilities in an effort to alleviate micromanagement,” said Thompson.
“I gather his idea is something along the lines of a company achieving a certification of competence to do certain validation testing or other quality assurance tasks, as a way to reduce the number of submissions for modifications,” he said. “That’s actually a very clever thought. It is consistent overall with the notion that the Good Manufacturing Practices assure that manufacturers are doing a certain amount of testing, and that so long as manufacturers are generally found to be in compliance with the GMPs, not every change requires FDA review. This simply takes that up a level.”
