Keep pulling the thread on Suzanne Levy Friedman.
Approximately a year ago, the FDA issued a final guidance document that provides manufacturers with a framework for truthfully disseminating scientific information about off-label uses of their devices.
The pace of innovation in the medtech industry, particularly with AI and software, is faster than the FDA's ability to regulate, creating tension between the industry and the agency.
The FDA has recently been issuing more practical guidance documents, which helps companies operationalize regulatory requirements sooner.
The FDA has issued a final guidance document on human factors materials for marketing submissions.
The FDA manages its limited resources by setting a list of priority areas on which to focus its guidance document development.
Human factors has recently been a major area of focus and a significant challenge for the FDA in medical device regulation.