He added that CDRH maintains a list of countries that won't cooperate with the requirement and tells manufacturers to check the list and report if they are having problems getting an approval letter, whereupon FDA will allow an alternative. But HIMA retorts that such a practice would turn the demonstration into a mandatory labeling requirement. The company should have very good records that show what goes in and what comes out. It's as simple as that. Focus on Risk Management CDRH's Office of Compliance is planning a series of industry training seminars that will focus on risk management.
Risk management covers everything from device design to manufacturing to marketing.
Training will emphasize total risk management, and not focus simply on design control. AAMI is also working on standards for risk management. That is one conclusion drawn from dozens of pages of FDA correspondence prepared in response to scores of questions from the House Commerce Oversight and Investigations subcommittee. However, unlike home-ground inspections, FDA will only get documents from EU members if it explicitly requests them in each case. The question of FOIA document release was a potential deal breaker that threatened to wreck the MRA at one point, but the Europeans relented after their local industries agreed to yield to U.S. practice and law in order to consummate the agreement.