21 U.S.C. § 360g–2 — Third party data transparency

(a) In general. Whenever the FDA relies on data, analysis, or other findings from a group that was funded in whole or in part by the FDA, or that worked for the FDA under contract, to make a device-related regulatory decision, the FDA must: (1) ask for access to the underlying datasets, inputs, assumptions, methods, computer code, results, and other pieces behind that analysis; and (2) when that information is used to support the decision, and where practical and appropriate, give the affected manufacturer or manufacturers a summary of it — while still protecting confidential business information, trade secrets, and personally identifiable information. (b) Report. Starting September 30, 2023, and every two years after that, the FDA must send a report to the same two Congressional committees, and publish it on the FDA's website, on how many postmarket device safety signal communications it issued, where the data for those signals came from, and how each signal was revised or resolved. (c) Rule of construction. Nothing in this section requires the FDA to delay any regulatory decision or other action because of these requirements.