FDA’s device center issued simplified standard operating procedures Sept. 4 for resolving “internal differences of opinion in regulatory decision making.” The SOPs describe a stepwise approach for a reviewer who disagrees with a peer or manager on a scientific, clinical or regulatory issue to register his or her views via the CDRH ombudsman and have them assessed at a higher management level. It also describes an appeals process that goes progressively up the chain of command at CDRH and FDA, if necessary, and some specific timelines guiding the process.
The document replaces a much longer October 2009 version
