On Sept. 21, 2016, the National Institutes of Health (NIH) announced final rule requirements for submitting registration and summary results information.

The requirements included adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine, The regulations was effective on Jan. 18, 2017.