FDA Update On National Reporting Standard
Federal U.S. legislation signed last year mandated that the FDA develop a national “density” reporting standard to be included in patient letters and health provider reports (learn more HERE).
The March 2019 proposed rule/language is still in the development process and we reached out to our friends at the FDA for an update. Feedback provided is that the most current information regarding publication of the rule is still the Spring 2020 Unified Agenda which anticipates that the final rule will be published in September 2020. At that time, we will also learn the implementation period of the new rule (proposed period was 18 months).
We will keep you apprised of developments as we learn them!