FDA tightening its approval process

Fish’s Keith Barritt was quoted in The Daily Transcripts article, FDA tightening its approval process.

“Things are getting more difficult to get through the medical device authorization process,” said trademark attorney Keith Barritt, a principal in the Washington, D.C. office of Fish & Richardson PC. “It’s because the FDA is trying to be more focused on determining the safety and effectiveness of the medical devices they authorize when the statutory standard (for Class II devices) is substantially equivalent.”